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

Catalog Number XC200

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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? what do you mean by ""the ratchet of the 3 clips did not lock during use.""? was the issue related to clips? yes.3clips could not be fixed to the suture.Or was the issue related to applier device component? no.Were the clips able to hold the suture in tissue intra-op? no.If clip did not close/did not hold on the suture, was the clip used in an application where the suture was under tension? no further information is available.Confirm if total qty of 3 clips involved that were reported with issue during use on single procedure/patient? yes.Were the clips able to be loaded on the applier jaws? no further information is available.When the even occurred, was the suture placed near the hinge of the clip? no further information is available.Was the applier checked for damage (jaws straight and aligned)? no further information is available.No further information will be provided.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2019 and suture clips were used.The clip did not lock during use.Another device was used.There were no adverse consequences to the patient.

• 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 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8353973
• MDR Text Key: 136860503
• Report Number: 2210968-2019-78957
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XC200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1