HARMONIC SCALPELS/SHEARS
Received Jan 24, 2022 · Event occurred Dec 1, 2021
Report 2134070-2022-00002 · MDR key 13334024
Device
Generic name
Electrosurg, Cut/coag Accessories, Laparoscopic & Endoscopic, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
HAR36RCatalog number
HAR36R
Lot number
2163998
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS, THE BLADE BROKE OFF AND WAS RETRIEVED. IT IS UNKNOWN AS TO HOW THE BLADE WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
WE COULD NOT CONFIRM THE REPORTED ISSUE BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RECEIVED FOR EVALUATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR THE FINISHED DEVICE LOT 2163998 AND NO NONCONFORMANCES WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).