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

Model Number	IDRVULTRA2
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Failure to Fire (2610)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/03/2018
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, pre-operatively, the stapler was not able to fire.The handle only had blue light on and they tried three batteries that were completely charged that worked perfectly well with another handle.There was no patient involvement.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IDRIVE ULTRA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7905703
• Report Number: 1219930-2018-05200
• Device Sequence Number: 1653850
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1