inforMED
InjuryGET

ROTICULATOR ENDO DISSECT* 5MM INSTRUMENT

Received Jan 24, 2017 · Event occurred Dec 15, 2016

Report 2647580-2017-00081 · MDR key 6273988

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174213

Catalog number

174213

Lot number

P5D461X

Product problems

  • Failure to Cut
  • Failure to Cut

Patient

48 YR

  • Tissue Damage
  • Blood Loss
  • Tissue Damage
  • Blood Loss

Narrative

Additional Manufacturer Narrative

(B)(4).

Additional Manufacturer Narrative

FTR# (B)(4). PATIENT INFORMATION NOT PROVIDED. PHONE NUMBER: NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PRODUCT WAS USED WITH MONOPOLAR CAUTERY, BUT DID NOT CAUTERIZE, WHICH CREATED A DEFECT IN THE TISSUE. THERE WAS BLEEDING BECAUSE THERE WAS NO CONNECTION WITH THE CAUTERY. TO CORRECT THIS CONDITION, ANOTHER PRODUCT WAS OPENED. THE BLEEDING FIRST PART WAS BURNED. TISSUE DAMAGE WAS SEEN. THERE WAS UNANTICIPATED TISSUE LOSS.

Description of Event or Problem

ADDITIONAL INFORMATION PROVIDED: "BLEEDING HAS BEEN IN PART BECAUSE THERE WAS NOT CONNECTION WITH CAUTERY. ANOTHER PRODUCT WAS OPENED. BLEEDING FIRST PART WAS BURNED."

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL AND FUNCTIONAL TESTING NOTED NO ABNORMALITIES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. OUR INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE OR ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT. BASED ON THE EVIDENCE AVAILABLE, THE REPORTED CONDITION WAS NOT CONFIRMED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PRODUCT WAS USED WITH MONOPOLAR CAUTERY, BUT DID NOT CAUTERIZE, WHICH CREATED A DEFECT IN THE TISSUE. THERE WAS BLEEDING BECAUSE THERE WAS NO CONNECTION WITH THE CAUTERY. TO CORRECT THIS CONDITION, ANOTHER PRODUCT WAS OPENED. THE BLEEDING FIRST PART WAS BURNED. TISSUE DAMAGE WAS SEEN. THERE WAS UNANTICIPATED TISSUE LOSS.