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

Model Number LT200

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy for chronic (b)(6), chronic cholecystitis, upon unpacking the device, the visiting nurse found that there were no local labels in the small packaging of the product (labels of the device in (b)(6)).Changed to another device to complete the surgery.There was no patient consequence reported.This case is from the health authority.No additional information can be provided.

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 12841071
• MDR Text Key: 282915329
• Report Number: 3005075853-2021-07052
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 175A84
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male