MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC PROXIMATE; STAPLE, REMOVABLE (SKIN)

Model Number	PRW35
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Operating room staff reported that a stapler was not working during a procedure.A new stapler was opened and used without issue.The procedure was completed as planned with no harm to the patient, and the stapler will be returned to the manufacturer by or material's management staff.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 9882561
• Report Number: 9882561
• Device Sequence Number: 492679
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020
• Report Date (Section F): 02/14/2020

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: No Information
• Device Model Number: PRW35
• Device Catalogue Number: PRW35
• Device Lot Number: T40Z7W
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 02/14/2020