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

Catalog Number	PPH03
Medical Device Problem Codes	Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 11/12/2025.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: could you please provide more details about the type of oozing? was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? how was the bleeding controlled? how much blood was lost (ml)? did the patient require a transfusion? what degree of hemorrhoids did the patient have? what confirmation was received that the device was fully fired? where within the gap setting scale was the orange indicator prior to firing? did the device cut? if the device cut was the cut line fully circumferential around the target tissue? did the device staple? was the staple line complete? were there any staples missing from the staple line? what was the appearance of the deployed staples (b-formation, irregular, straight legs)? how many counter-clockwise revolutions were used to open the device? was the safety reset before removal attempted? how many counter-clockwise revolutions were used to open the device? how was it confirmed that the anvil was free from the tissue prior to removing? after firing was the adjusting knob turned ½ to ¾ revolutions? was the device rotated 90 degrees in both directions to ensure the anvil was free from the tissue? who fired the device? who removed the device? what was the users experience with the device? how was the procedure completed? was there any patient consequence or change in the post-operative care of the patient as a result of the event? 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 a colon anastomosis surgery in a patient treated by dr., the stapler was used.When shooting, the stapler did not perform stapling and stopped working.This caused excessive bleeding and the surgery was prolonged, as manual stapling was necessary.There were no patient consequences.

• Brand Name: PROXIMATE
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23533194
• Report Number: 3005075853-2025-08752
• Device Sequence Number: 15719623
• Product Code: GDW
• UDI-Device Identifier: 10705036013006
• UDI-Public: (01)10705036013006(17)291031(10)344D11(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K051301
• 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,Followup
• Report Date (Section B): 05/04/2026

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: PPH03
• Device Lot Number: 344D11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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