MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Model Number LT200

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Pc (b)(4).Batch # unk date of event is 2020.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain additional information and retrieve the device.To date, no additional information has been received and no device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent: please clarify the "coming out malformed clips", was during firing that the clips does not form completely, forms a pear/tear drop shape or clip gap? if other, please specify please provide the status of the device(s) as it has not been received for analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during and unknown procedure, some clips in the lt200 cartridge were falling out in theatre or coming out malformed.There was no delay to procedure and other clips were used.Surgery was successfully completed and there was no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 2/8/2021.H6: component code: others (g07).Investigation summary: only product packaging was returned for evaluation and as no device was returned, no visual inspection and functional testing could not be conducted.Visual analysis of the returned packaging revealed that the lt200 open package was empty and no reload or clips were returned for analysis.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.As part of our 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10997415
• MDR Text Key: 221290852
• Report Number: 3005075853-2020-06753
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: 10705036012801
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT200
• Device Catalogue Number: LT200
• Device Lot Number: U40C8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/18/2021
• Patient Sequence Number: 1