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

Model Number	030805L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/14/2017
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: occurred during a laparoscopic appendectomy.After the device had fired there was bleeding from the staple line.The case was completed using clips.No patient injury.

• 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: 7037513
• Report Number: 2647580-2017-07844
• Device Sequence Number: 19086211
• Product Code: GDW
• UDI-Device Identifier: 20884523003762
• UDI-Public: 20884523003762
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 11/30/2021
• Device Model Number: 030805L
• Device Catalogue Number: 030805L
• Device Lot Number: P6L0626MX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1