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

Model Number	PRW35
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The ethicon endo-surgery proximate rotating head skin staplers device (model prw35) was used on a patient during a surgical case.The device worked as expected with the first three staples.Then, the device malfunctioned and would not load or discharge any more staples.The defective device was removed from the surgical field and placed in a bag while a new proximate device was opened to continue the surgery.

• 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: 10380413
• Report Number: 10380413
• Device Sequence Number: 2186252
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/29/2020
• Report Date (Section F): 07/29/2020

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: Other
• Device Model Number: PRW35
• Device Catalogue Number: PRW35
• Device Lot Number: U40A0E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/29/2020