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

Model Number IDRVULTRA1

Device Problems Failure to Calibrate (2440); Failure to Fire (2610); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during lower lobe resection, three firings to interlobar tissue were successful.The surgeon clamped the inferior pulmonary artery with the reload and pushed the green firing button but the device did not react at all.The jaws opening/closing were checked beforehand.Reconnected the reload to the adapter, however, the device did not recognize the reload.They inserted another battery to the handle and the surgeon resected the inferior pulmonary artery by ligature.After the replacement of the battery, they connected another reload to the adapter and checked jaws opening/closing, however, the reload did not react smoothly and the jaws did not close properly.They said a strange sound was heard at the calibration.The surgical time was extended by less than 30 minutes.The device was replaced by competitor's device and the procedure continued.They could not identify which battery they used first, due to the same serial number.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were noted.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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition; therefore, a review of the device history record was not performed.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No enhancements or improvements were generated for the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IDRIVE ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7367332
• MDR Text Key: 103358508
• Report Number: 1219930-2018-01634
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142794
• UDI-Public: 10884521142794
• Combination Product (y/n): N
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1