MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030813
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the appendix was carefully delimited and mobilized with a hook.When the team was about to fire the device, the team had a discussion who will fire the device.When it was decided and when they pulled the stapler out of the port, the user got an open stapler that the reload was missing.It was reported that the reload was in the patient and the user increased 5 mm port to 12 mm port for the reload to be retrieved and was placed in a bag.No intestinal damage was noticed.The surgeon used another stapler to resolve the issue.The device was placed in a second bag.Both bags were taken out of the umbilical gate.Surgeon observed minor bleeding that has been stopped with a napkin.No further patient complication reported.

• Brand Name: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10283352
• Report Number: 2647580-2020-02178
• Device Sequence Number: 16857363
• Product Code: GDW
• UDI-Device Identifier: 10884523003796
• UDI-Public: 10884523003796
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 030813
• Device Catalogue Number: 030813
• Device Lot Number: P0B1423MY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1