ROTO-LOK GRASP FCP 5MM W/LEVER
Report
- Report Number
- 2523190-2019-00129
- Event Type
- Malfunction
- Date Received
- October 25, 2019
- Date of Event
- August 3, 2019
- Report Date
- October 10, 2019
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- GCJ
- PMA / PMN Number
- K931928
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION RECEIVED 18NOV2019 REPORTED THAT THE PRODUCT INVOLVED WAS NOT FOR THE INTEGRA JARIT GRASPER AS INITIALLY REPORTED, BUT CONFIRMED AS A VMUELLER GRAPSER, PRODUCT NUMBER LA8203, NOT AN INTEGRA PRODUCT. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. LOT NUMBER NOT PROVIDED TO PERFORM DEVICE HISTORY RECORD REVIEW. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED. THE REPORTED COMPLAINT IS UNCONFIRMED. DEVICE IDENTIFIER: (B)(4).
N/A.
N/A.
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
REPORT NUMBER: (B)(4) RECEIVED ON 10/10/2019 (MEDWATCH). IT WAS REPORTED THAT ON (B)(6) 2019, DURING A LAPAROSCOPIC PORTION OF THE SURGERY, THE 625100LL ROTO-LOK GRASP FCP 5MM W/LEVER, THE BLUNT LOCKING GRASPER INSTRUMENT BROKE. A SMALL PIECE (APPROXIMATELY 05.CM SQUARE) OF BLACK PLASTIC NEAR THE TIP OF THE INSTRUMENT BROKE OFF THE SHAFT WHILE INSIDE THE PATIENT'S ABDOMEN. THE PIECE WAS SEEN IN THE ABDOMEN, BUT UPON SWITCHING OUT THE INSTRUMENTS TO RETRIEVE THE PIECE, IT DISAPPEARED. THE PIECE WAS NOT RETRIEVABLE AFTER SEARCHING THE ABDOMINAL CAVITY. ANOTHER STERILE INSTRUMENT REPLACED THE BROKEN ONE AND THE SURGERY CONTINUED AS PLANNED. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1033742 | ROTO-LOK GRASP FCP 5MM W/LEVER | GRASPING FORCEPS | GCJ | INTEGRA YORK, PA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |