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

Model Number	IDRVULTRA2
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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, when stapling the stomach during a laparoscopic gastric bypass, the handle was able to recognize the reload and was bale to fire but had an unloading problem.It was also stated that the jaws of the device locked on tissue.The adapter has been disconnected and reconnected in order to open the jaws and retrieve the device.There was no patient injury.
Additional Manufacturer Narrative
Additional information:g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual analysis noted that paint was worn off of both the close/fire button and the open/retract button.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.During inspection of the eeprom, the following code of drive_motor_stop_quad_fail.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.Additionally, the investigation detected a unreported condition of improper cleaning that has no relationship to the reported condition.The error code of "drive_motor_stop_quad_fail" can be attributed to moisture on the board.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: 9634973
• Report Number: 1219930-2020-00434
• Device Sequence Number: 2535134
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/09/2020

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: 01/20/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1