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

Model Number	030805L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The visual inspection and functional evaluation of the device had acceptable results.A review of the device history record indicates the product was released meeting all medtronic 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.No enhancements or improvements were generated for the reported condition.Based on the evidence available the reported condition was not confirmed.The file will be closed as fired satisfactorily.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic appendectomy procedure, there was poor staple formation on the distal end of the staple line.Malformed staples were removed from the patient.Another stapler was used 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: 6769642
• Report Number: 2647580-2017-05865
• Device Sequence Number: 187079
• Product Code: GDW
• UDI-Device Identifier: 10884523003765
• UDI-Public: 10884523003765
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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: 08/31/2019
• Device Model Number: 030805L
• Device Catalogue Number: 030805L
• Device Lot Number: P4H0349X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1