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

Model Number LT200

Device Problems Failure to Form Staple (2579); Appropriate Term/Code Not Available (3191); Firing Problem (4011)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.Date of event is 2021.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts are being made to retrieve the device.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.

Event Description

It was reported that during an unknown procedure, the clips were falling out of the device and were placed crooked.They couldn¿t be fired, nor placed.There was no risk involved (patient consequence not reported).No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 8/25/2021.D4: batch # u40c8w.Investigation summary: the analysis results of the lt200 cartridge found that it was received with only two clips loaded.No damage on the cartridge was noted as the cover and base were observed properly attached.The cartridge was tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained, and deployed two clips as intended.The clips were formed as intended and conforming to our manufacturing requirements.Analysis does not confirm (verify) the reported failure.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch 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: 12178591
• MDR Text Key: 262267889
• Report Number: 3005075853-2021-03943
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 08/04/2021
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1