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

Model Number	IDRVULTRA2
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
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 laparoscopic sleeve gastrectomy, on first firing of stapler on the stomach, the staple line was incomplete centrally.Another reload was placed on the same handle and finished the staple line.There was no patient injury.
Additional Manufacturer Narrative
This report was sent in error as a duplicate for mfr report number: 1219930-2018-04565, any additional information received in the future will be captured and submitted under the report number 1219930-2018-04565.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Duplicate of product event : (b)(4).

• 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: 7793340
• Report Number: 1219930-2018-04558
• Device Sequence Number: 1117142
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1