MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY ABSORBABLE X6::SUTURE CLIP; CLIP, IMPLANTABLE

Catalog Number XC200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device pd2285 / xc20002, and no non-conformance were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent laparoscopic anterior resection on (b)(6) 2019 and suture clip was used.During the procedure, the suture came off the clip of the cartridge easily when the device was used on the rectum to stop the bleeding.Another clip was fed into an applier outside the patient for functionality, and the ratchet mechanism did not work properly.Some clip came off the applier soon after they were fed into the applier.A nurse commented that 4 clips of lot cartridge pd2285 had those problems in total.Another device was used to complete the case.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).The analysis results of the xc200 cartridge found that it was received empty and with six clips loose inside of a plastic bag, five clips closed and a clip open.No damaged on the cartridge was noted as both the cover and base were observed properly attached.Lot records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The reload was received empty and no damaged were observed.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9263084
• MDR Text Key: 166130154
• Report Number: 2210968-2019-89335
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: XC200
• Device Lot Number: PD2285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/22/2019
• Patient Sequence Number: 1