MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG MULTIFIRE ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030807L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The event report alleges the products were used in a surgical procedure.The visual inspection and functional evaluation of the devices had acceptable results.A review of the device history record could not be performed because the lot number was not provided.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.
Event or Problem Description
According to the reporter: during laparoscopic appendectomy procedure, the device was stapled the line incomplete.To finish the procedure, the surgeon hand sewn the opening where the appendix was taken off.No patient injury has been noted.

• Brand Name: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6801496
• Report Number: 1219930-2017-06483
• Device Sequence Number: 878078
• Product Code: GDW
• UDI-Device Identifier: 10884523003772
• UDI-Public: 10884523003772
• 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): 07/19/2017

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 Model Number: 030807L
• Device Catalogue Number: 030807L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1