MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN IDRIVE; STAPLE, IMPLANTABLE

Model Number	INTB100
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
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 low anterior resection of rectum, while performing double stapling, the device stopped working while clamping tissue on the first firing.The battery was reset to remove the device from the tissue, then reassembled the device to complete the procedure.There was no reported patient involvement and outcome.

• Brand Name: IDRIVE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7433111
• Report Number: 1219930-2018-02030
• Device Sequence Number: 11161015
• Product Code: GDW
• UDI-Device Identifier: 10884523007107
• UDI-Public: 10884523007107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: INTB100
• Device Catalogue Number: INTB100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1