PAL INSTRUMENT CABLE

Description of Event or Problem

MICROAIRE SURGICAL INSTRUMENTS WAS NOTIFIED ON (B)(6) 2022 BY EMAIL THAT A "CUSTOMER HAD A PROBLEM DURING A DEMONSTRATION IN WHICH HE WAS USING THE PAL SYSTEM AND THE PATIENT HAS BURNS ON BOTH LEGS."

Additional Manufacturer Narrative

MICROAIRE SURGICAL INSTRUMENTS, LLC WAS NOTIFIED VIA EMAIL ON (B)(6) 2022 THAT THE PATIENT SUSTAINED SECOND AND THIRD DEGREE BURNS. THE PATIENTS REQUIRED BOTH DEBRIDEMENT AND OINTMENT PLACEMENT FOR TREATMENT OF THE BURNS AND THE SURGERY WAS NOT EXTENDED. THE FOLLOWING MICROAIRE BRANDED DEVICES WERE USED DURING THE ASSOCIATED EVENT; PART NUMBER: PAL-650 SERIAL NUMBER: (B)(4) THIS DEVICE WAS MANUFACTURED ON 03-10-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON (B)(6) 2020 AND ORIGINAL SHIPMENT DATE OF (B)(6) 2020 TO THE DISTRIBUTOR. PART NUMBER: 5020 SERIAL NUMBER : (B)(4) THIS DEVICE WAS MANUFACTURED ON 07-21-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON (B)(6) 2020 AND ORIGINAL SHIPMENT DATE OF (B)(6) 2020 TO THE DISTRIBUTOR. PART NUMBER: 5006-PAL SERIAL NUMBER: (B)(4) THIS DEVICE WAS MANUFACTURED ON 03-18-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON (B)(6) 2020 AND ORIGINAL SHIPMENT DATE OF (B)(6) 2020 TO THE DISTRIBUTOR. AT THE TIME OF THIS REPORT, THE DEVICE(S) HAVE NOT BEEN RETURNED TO MICROAIRE SURGICAL INSTRUMENTS FOR DIAGNOSTIC TESTING. ONCE THE DEVICE(S) ARE MADE AVAILABLE, THIS REPORT WILL BE UPDATED WITH THE RESULTS OF THE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD ASSOCIATED WITH EACH OF THE AFOREMENTIONED PART NUMBERS AND SERIAL NUMBERS DID NOT REVEAL ANY ANOMALIES THAT WOULD RESULT IN THE REPORTED EVENT AND IT HAS BEEN NOTED THAT NONE OF THE DEVICE(S) HAVE BEEN RETURNED TO MICROAIRE SURGICAL INSTRUMENTS FOR ROUTINE INSPECTION/SERVICE/REPAIR SINCE THE ORIGINAL SHIP DATE OF (B)(6) 2020.

Additional Manufacturer Narrative

THE END-USER AND DISTRIBUTOR OF THE PAL SYSTEM STATE THAT THE (3) DEVICES USED WITHIN THE SURGERY THAT CAUSED THE PATIENT TO SUSTAIN SECOND AND THIRD DEGREE BURNS AND REQUIRED DEBRIDEMENT AND OINTMENT PLACEMENT FOR THE BURNS WOULD NOT BE RETURNED FOR EVALUATION. THE FOLLOWING MICROAIRE BRANDED DEVICES WERE USED DURING THE ASSOCIATED EVENT: 5006-PAL SN # (B)(6) WHICH WAS MANUFACTURED ON 03-18-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON 03-19-2020 WITH AN ORIGINAL SHIPMENT TO THE DISTRIBUTOR ON 07-23-2020. PAL-650 SN # (B)(6) WHICH WAS MANUFACTURED ON 03-10-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON 03-16-2020 WITH AN ORIGINAL SHIPMENT TO THE DISTRIBUTOR ON 07-23-2020. 5020 SN # (B)(6) WHICH WAS MANUFACTURED ON 07-21-2020, TRANSFERRED TO FINISHED GOODS INVENTORY ON 07-22-2020 WITH AN ORIGINAL SHIPMENT TO THE DISTRIBUTOR ON 07-23-2020. A REVIEW OF THE DEVICE HISTORY RECORD ASSOCIATED WITH EACH OF THE AFOREMENTIONED PART NUMBERS AND SERIAL NUMBERS DID NOT REVEAL ANY ANOMALIES THAT WOULD RESULT IN THE REPORTED EVENT AND IT HAS BEEN NOTED THAT NONE OF THE DEVICE(S) HAVE BEEN RETURNED TO MICROAIRE SURGICAL INSTRUMENTS FOR ANNUAL INSPECTION/SERVICE/REPAIR SINCE THE ORIGINAL SHIP DATE OF 07-23-2020. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE; HOWEVER, POTENTIAL USER-RELATED CAUSES OF THE REPORTED INCIDENT INCLUDE NOT COMPLETING PRE-OP TESTING OF THE DEVICES PRIOR TO SURGERY AND USING THE PATIENTS BODY AS A TABLE TO LAY THE INSTRUMENTS/CABLE DURING THE SURGERY.

Description of Event or Problem

MICROAIRE SURGICAL INSTRUMENTS WAS NOTIFIED ON 05-30-2022 BY EMAIL THAT 'A CUSTOMER HAD A PROBLEM DURING A DEMONSTRATIONS IN WHICH HE WAS USING THE PAL SYSTEM AND THE PATIENT HAS BURNS ON BOTH LEGS'.