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

Model Number	IDRVULTRA2
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy procedure, while the device was being applied to the stomach, the device stopped firing the reinforced reload after once centimeter.There was an incomplete staple line proximally.The staple line was fixed normally using new reload.They cut the reinforcement reload and they used manual stapler to complete the case.The surgical time was extended by more than 30 minutes due to the product problem.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the adapter noted no abnormalities.The eeprom was uploaded and indicated 92 autoclave cycles for the handle.Evaluation of the eeprom noted that the code drive_motor_ excessive_load_mode was present.This was indicative of a thick tissue application and could confirm the reported condition.A pmv representative adapter and reload 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Replication of the drive_motor_excessive_load_mode error codes may occur of the idrive ultra powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the endo gia reload.This may occur under the following conditions.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In either scenario, staples may not form properly and tissue may not be fully transected.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 8230964
• Report Number: 1219930-2019-00174
• Device Sequence Number: 13889680
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1