LAPRA-TY ABSORBABLE X6::SUTURE CLIP
Report
- Report Number
- 2210968-2022-08230
- Event Type
- Malfunction
- Date Received
- October 5, 2022
- Date of Event
- September 13, 2022
- Report Date
- November 1, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- FZP
- UDI-DI
- 10705031206885
- PMA / PMN Number
- K931492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: * WHAT SUTURE TYPE WAS USED? * WHAT SUTURE SIZE WAS USED? * WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? * WERE YOU ABLE TO LOCK THE CLIP CLOSED ON THE SUTURE? IF YES AFTER IT CLOSED, WAS THE CLIP HOLDING SECURELY FIXED ON THE SUTURE? * WAS THE APPLIER CHECKED FOR DAMAGE (JAWS STRAIGHT AND ALIGNED)? * WHAT WAS THE SURGICAL PROCEDURE INVOLVED? * WAS THIS A ROBOTIC PROCEDURE? * IF CLIP DID NOT CLOSE/DID NOT HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? * WHAT IS THE LOT NUMBER? * DEVICE RETURN STATUS/FOLLOW UP? FOLLOW UP WITH THE TECH THAT WAS INVOLVED WITH ATTACHING THE LAPRATY. THE ISSUE WAS WITH KA200 HANDLES. TWO HANDLES WITHIN THE INVENTORY HAVE BEEN IDENTIFIED AS DAMAGED AND HAVE BEEN SUBMITTED TO BE REPLACED. THE LAPRATY CLIPS HAVE BEEN KEPT AND SHIPPED OFF TO ENSURE THAT THERE IS NOTHING WRONG WITH THE CLIPS, ONLY THE HANDLES. THE LOT NUMBERS ARE SC2AKP AND SC2ADR. SURGICAL PROCEDURE WAS A ROBOTIC ROUX EN Y GASTRIC BY PASS. THE SUTURE WAS NOT IN PLACE THAT IT WAS UNDER TENSION. THE ISSUE WAS PRIOR TO OPERATION AS THE TECH WAS SETTING UP. SUTURE WAS VICRYL, I AM WAITING ON SPECIFIC SIZE THAT WAS USED AND PLACEMENT OF SUTURE WITHIN CLIP. I WILL UPDATE WHEN I RECEIVE THAT INFORMATION. CURRENTLY THE DEVICES HAVE BEEN DROPPED OFF AT FEDEX TO BE SHIPPED OUT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT RELATED TO:: 2210968-2022-08229, 2210968-2022-08230
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/01/2022 H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED RELOAD. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE XC200 RELOAD WAS RECEIVED WITH NO APPARENT DAMAGE AND A RELOAD WITH 5 CLIPS LOADED. HOWEVER, THE CLIPS WERE NOTED TO BE MOVED INSIDE OF THE CARTRIDGE; DUE TO IMPROPER HANDLING OF THE CLIPS. THE CLIPS WERE ACCOMMODATED IN THE RELOAD AND LOADED ON A TEST DEVICE AND TESTED FOR FUNCTIONALITY. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED THE CLIPS AS INTENDED. DUE TO THE CONDITION OF THE CLIPS, THE REPORTED COMPLAINT WAS CONFIRMED BY AN EXTERNAL CAUSE AS IMPROPER HANDLING. ENSURE THE TIPS OF THE APPLIER ARE PERPENDICULAR TO THE SURFACE OF THE CARTRIDGE. INSERT THE APPLIER UNTIL IT STOPS. DO NOT FORCE THE APPLIER. IT SHOULD ENTER AND WITHDRAW FROM THE CARTRIDGE SMOOTHLY. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. POTENTIAL LOT INVOLVED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) /XC20002 AND NO NON CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. MFG. DATE: 03/14/2022 EXPIRY DATE: 02/28/2025 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) /XC20002 AND NO NON CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. MFG. DATE: 03/07/2022 EXPIRY DATE: 02/28/2025.
IT WAS REPORTED BY THE SALES REP THAT THE ROBOTIC NURSING COORDINATOR REPORTED TWO INCIDENCE WHERE XC200 LAPRATY DID NOT FUNCTION PROPERLY DURING A ROUX-EN-Y. THE TECH WAS PREPARING THE LAPRATY BY ATTACHING IT TO THE KA200 HANDLE. THE LAPRATIES DID NOT ATTACH TO THE HANDLE AND A NEW BOX HAD TO BE OPENED BEFORE THE DEVICE FUNCTIONED PROPERLY. THE TECH WAS PREPARING THE DEVICE BEFORE THE CASE AND THE OCCURRENCES DID NOT SLOW UP THE PROCEDURE. IT WAS COMPLETED WITH NO PATIENT CONSEQUENCES. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1418630 | LAPRA-TY ABSORBABLE X6::SUTURE CLIP | CLIP, IMPLANTABLE | FZP | ETHICON INC. | XC200 | 10705031206885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |