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

Model Number LT200

Device Problems Difficult to Insert (1316); Failure to Form Staple (2579); Defective Device (2588)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

Pc-(b)(4).Date sent: (b)(6) 2022.Batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide more details about statement ¿liga clips in cartridge are malformed¿ during the firing the clip does not form completely or form a pear/ tear drop shape? or were just malformed on the cartridge and not able to load correctly on the jaws? if other, please specify investigation summary this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows a malformed clip out of the cartridge.The product code for this complaint should be lt200 ligaclip*extra titanium clips.Based on the photo review, the event describe 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.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.

Event Description

It was reported that the liga clips in cartridge are malformed and occasionally fell out of cartridge and clip the action taken.Monitored and counted to ensure not left in patient.No patient harm.

• 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 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13967058
• MDR Text Key: 289271509
• Report Number: 3005075853-2022-01943
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: 380A22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1