MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD THICK TISSUE; STAPLE, IMPLANTABLE

Catalog Number	TRT10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 1/2/2025.B3 exact date is unk.Assumed first month of the year.D4 batch # unk.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.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: did the reload lockout and would not work? did the reload begin to staple and cut, but then jammed? did the device staple? if the device staple, was the staple line complete? if the device staple, what was the shape of the staples (b-formation, irregular, legs straight)? did the device cut? if the device cut, was the cut line complete? were the cut line and staple lines equal? did the device staple, but there was no cut line? 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 the device did not loose any staples during use.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/16/2025.Corrected data; b1, h1.Additional information was requested, and the following was obtained: 1.Did the reload lockout and would not work? device was normal.2.Did the reload begin to staple and cut, but then jammed? device jammed while stapling.3.Did the device staple? no.4.If the device staple, was the staple line complete? no.6.Did the device cut? device removed without cutting.7.If the device cut, was the cut line complete? no.8.Were the cut line and staple lines equal? no.9.Did the device staple, but there was no cut line? no.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.

• Common Device Name: STAPLE, 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: 21054803
• Report Number: 3005075853-2025-00018
• Device Sequence Number: 8023345
• Product Code: GDW
• UDI-Device Identifier: 10705036003236
• UDI-Public: 10705036003236
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K020779
• 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
• Report Date (Section B): 01/16/2025

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: TRT10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown