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

Catalog Number	MCL20
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/26/2024.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: batch # unk.Additional information was requested and the following was obtained: "no patient consequences, the surgeon could manage".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.
Event or Problem Description
It was reported that during an unknown procedure, clip applier is not closing easily.Some staples didn't close properly.Placenta previa bleeding.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/23/2024.Correction: d4.Primary udi number.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/19/2024.D4: batch # unk.This is an analysis for a video submitted to ethicon for evaluation.During visual analysis the following was observed: the video shows a ligaclip*mca large applier product code mcl20 the sample is observed forming and ejecting clips when activated by the user, it is observed with fluids in the area of the jaws.Based on the video 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.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.

• Common Device Name: 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: 20309512
• Report Number: 3005075853-2024-07252
• Device Sequence Number: 8838142
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: (01)10705036002468(17)270831(10)998A45
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K820837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: MCL20
• Device Lot Number: 998A45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/29/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown