MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER420

Device Problem Failure to Form Staple (2579)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, there was attempts to fire the clip applier about three to four times, all of the attempts the clips were firing in a "criss-cross" manner, thus making the clip applier ineffective upon use.A new clip applier was opened to the field.No injury to patient.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 3/14/2024.D4: batch # unk.Maude report number: #mw (b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts have been 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 5/21/2024.D4: batch # unk.This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show four malformed clips used in surgery.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18902036
• MDR Text Key: 337639702
• Report Number: 3005075853-2024-02174
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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 Catalogue Number: ER420
• Device Lot Number: A9D10J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR