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 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.If the product is received at a later date, the investigation will be updated as applicable.Additional information received: a photo was received for review.During the visual analysis, the following was observed: the photo shows a white reload with a clip that appears loaded more to one side and a loose clip with an "s" shape.Based on the photo, the event described is confirmed, however, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned, our evaluation is limited.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 an unknown procedure, the new cartridge of lt200 was opened on the sterile field, and two clips were found to be "not conforming and falling out." there was no delay to procedure, surgery was successfully completed, and there was no patient consequence.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13351357
• MDR Text Key: 288509385
• Report Number: 3005075853-2022-00511
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2022

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: 08/31/2023
• Device Model Number: LT200
• Device Catalogue Number: LT200
• Device Lot Number: R40Z0M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1