LAPRA-TY ABSORBABLE X6::SUTURE CLIP
Report
- Report Number
- 2210968-2024-10869
- Event Type
- Malfunction
- Date Received
- October 18, 2024
- Date of Event
- October 1, 2024
- Report Date
- December 2, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- FZP
- UDI-DI
- 10705031206885
- PMA / PMN Number
- K931492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED . 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: - PACKAGE LOT NUMBER OF THE CLIPS? 100ML2. - PLEASE PROVIDE THE APPLIER PRODUCT CODE AND LOT NUMBER? THE APPLIER IS A METAL REPOSABLE LAPRATY APPLIER. THE ONLY # I SEE ON IT IS: KA100. - PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? IF YES, PLEASE CREATE A PRODUCT COMPLAINT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). YES, BUT WE ARE UNABLE TO IDENTIFY WHICH APPLIER - WHAT SUTURE TYPE AND SIZE WAS USED? 2-0 VICRYL. - WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? YES. - 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? IT WAS DIFFICULT TO APPLY, BUT YES, THE CLIP WAS HOLDING ONCE SECURED. - WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)? YES, OPENED 3 TOTAL APPLIERS DURING THE CASE. - IF THE CLIP DID NOT CLOSE/HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? NO, THE SURGEON ASKED FOR 8 SUTURES PRELOADED ON THE CLIP. THE SURGICAL TECH TRIED HOLDING TENSION, BUT IT WAS VERY DIFFICULT. EXTRA CARTRIDGES WERE OPENED AND WASTED JUST TRYING TO PREP FOR THE SURGEON.
(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: G1, H6 CORRECTED: H6 TYPE OF INVESTIGATION (B18 - DEVICE DISCARDED) A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE CLIPS WERE USED. THE SURGEON COULD NOT CLIP THEM TOGETHER ON LOOSE SUTURE. OPENED ADDITIONAL PACKS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930434 | LAPRA-TY ABSORBABLE X6::SUTURE CLIP | CLIP, IMPLANTABLE | FZP | ETHICON INC. | 100ML2 | 10705031206885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |