MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*PLUS MD SKIN STPLR; REMOVABLE (SKIN)

Catalog Number	PMW35
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/24/2026.Investigation summary: the product was returned for thorough evaluation, which included visual inspections of the returned device.Visual analysis of the returned sample revealed that the pmw35 device was returned nonfunctional.The device was received with the cartridge partially detached from the handle due to insufficient handle weld on the upper handle directors.There are 10 staples left inside the magazine.No functional test was performed due to the condition of the device; however, the insufficient handle weld could have cause firing issues when the cartridge began to be detached from the handle.The separation of device has been correlated to the manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.699d28a manufacturing record evaluation was performed for the finished device lot number of 699d28 / 45pmw35, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an unknown surgery, after fired, noted the staples malformed.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Common Device Name: REMOVABLE (SKIN)
• 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 ; * ; 3035526892
• MDR Report Key: 24431400
• Report Number: 3005075853-2026-01579
• Device Sequence Number: 13322882
• Product Code: GDT
• UDI-Device Identifier: 10705036002642
• UDI-Public: (01)10705036002642(17)300731(10)699D28(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K833357
• 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
• Report Date (Section B): 02/24/2026

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: PMW35
• Device Lot Number: 699D28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown