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

Catalog Number	LX107
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the clips would not become secure and would slip off.No patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/17/2024.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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? did device not load clips? did device drop or eject clips? did device fire malformed clips? if other please specify" investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the lx107 device was returned nonfunctional as the jaws were damaged; therefore, the clips could not be loaded into the jaws.The event reported was confirmed and it is related to improper use of the device.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Common Device Name: APPLIER, SURGICAL, CLIP
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19763606
• Report Number: 3005075853-2024-05187
• Device Sequence Number: 18293894
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: LX107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown