MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP

Catalog Number LX107

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579); Insufficient Information (3190)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the clips aren't clipping properly and aren't effective.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 3/5/2024.B3: unknown, assumed first day of month that complaint was reported.D4: 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: "how did device not work? did device jammed (not fire clips)? did device not feed clips? did device drop or eject clips? did device sideways feed clips? did device fire malformed clips? did device fire scissored clips? if other please specify" 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: 3/14/2024.Additional information was requested and the following was obtained: "how did device not work? some fell out , some scissored.Did device jammed (not fire clips)? jamming wasn¿t a problem, clips fell out.Did device not feed clips? manual.Did device drop or eject clips? yes.Did device sideways feed clips? no.Did device fire malformed clips? yes.Did device fire scissored clips? yes.If other please specify".

Manufacturer Narrative

(b)(4).Date sent: 3/28/2024 upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 18840529
• MDR Text Key: 337656078
• Report Number: 3005075853-2024-01939
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LX107
• Device Lot Number: 2009FQGA13152092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1