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

Model Number XC200

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? contact did not know.What was used to complete the procedure? additional xc200 clips.How many of the suture clips were not staying clipped? - exact number unknown, but more than what was sent back.What is the lot number? mj7092.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture clips were used.During the procedure, the clips were not staying clipped.It was not reported how the procedure was completed.There were no adverse patient consequences reported.

Manufacturer Narrative

Date sent to the fda: 02/20/2020.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional h-3 summary: four cartridges with clips/reloads and two empty cartridges were received for evaluation.No damaged on the empty cartridges were noted as both the cover and base were observed properly attached.The analysis results found that clips/reloads received also with no apparent damaged.The reloads were tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the clips as intended.The clips were form as intended and aligned to our manufacturing requirements.The clips performed without any difficulties noted.

Manufacturer Narrative

Corrected h-3 summary: representative samples.Four cartridges with clips/reloads, two sterile clips/reloads and two empty cartridges were received for evaluation.No damaged on the empty cartridges were noted as both the cover and base were observed properly attached.The analysis results found that all clips/reloads received also with no apparent damaged.The reloads were tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the clips as intended.The clips were form as intended and aligned to our manufacturing requirements.The clips performed without any difficulties noted.

• 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: 9621749
• MDR Text Key: 177191404
• Report Number: 2210968-2020-00625
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: MJ7092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/22/2020
• Patient Sequence Number: 1