MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER

Catalog Number	EL314
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the clip did not close securely and in line.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event: only event year known: 2022.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.Photo analysis: this is an analysis of two photos submitted to ethicon for review.During the visual analysis the following was observed: the photographs show four malformed clips and the tip of a ligaclip*endo med/lg applier device, the picture is not clear to determine the failure mode.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.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturing records could not be reviewed as the batch number is unknown.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: was there any bleeding? if yes, how was the bleeding controlled? what amount of blood loss (mls) occurred? was a transfusion required? was there any change to the procedure as a result of the event? were there any patient consequences? if yes, please describe.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.

• Common Device Name: LIGACLIP*ENDO MED/LG APPLIER
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15264793
• Report Number: 3005075853-2022-05470
• Device Sequence Number: 17792099
• Product Code: HBT
• UDI-Device Identifier: 10705036003854
• UDI-Public: 10705036003854
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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: EL314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown