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

Model Number	IDRVULTRA2
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2018
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 a robotic laparoscopic lower anterior resection, on the rectum tissue, the stapler was not able to fire.The surgeon was able to press the green button and squeeze the handle but the jaws of the device lock on tissue and was removed by opening it.The surgical time was extended by thirty minutes or more and the surgeon had to switch to manual gun in order to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were noted.The electrically erasable programmable read-only memory (eeprom) was uploaded and indicated 11 autoclave cycles for the handle.A pmv representative adapter and single use loading unit (sulu) were connected to the subject handle and applied to test media.The device responded correctly and the reload was able to be fired.The reload cleanly applied staples and transected the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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: 7591416
• Report Number: 1219930-2018-03039
• Device Sequence Number: 18900772
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2018
• Initial Date Received by Manufacturer: 05/26/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1