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

Model Number	030805L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the device had acceptable results.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an appendectomy procedure, the tip/ jaws did not open.Another device was used in order to complete the case.There was 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: 6968549
• Report Number: 2647580-2017-07296
• Device Sequence Number: 16369492
• Product Code: GDW
• UDI-Device Identifier: 10884523003765
• UDI-Public: 10884523003765
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 030805L
• Device Catalogue Number: 030805L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1