MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problem Unintended Arm Motion (1033)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.

Event Description

According to the reporter, during a low anterior resection, the reload indicator light did not illuminate.The reload was unloaded and loaded a few times, and eventually the light was illuminated.However when the surgeon rotated the adapter, suddenly, the reload was articulated automatically.Right after that, the reload indicator light was turned off.There was no injury or adverse event reported.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) examined one powered handle and one adapter returned by the account.This evaluation was based on technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and pmv and engineering evaluations of the returned devices.No visual abnormalities were noted for the handle.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 3 autoclave cycles for the adapter and handle.The user interface features on the handle and adapter were found to function properly.A pmv representative battery was inserted into this handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the handler.The adapter was inserted onto the handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.A reload from our inventory was inserted onto the adapter and the system initially did not recognize the presence of a reload.Further investigation of the returned adapter noted that the system would intermittently not recognize the presence of the reload when the adapter.The system was intermittently able to regain reload recognition and articulated during recalibration.The adapter was disassembled for examination of internal components.The solder connections were examined and determined to be cracked.The cracked solder joint condition prevented the switch from making a consistent electrical connection with the system in all rotational orientations.It is when a lost recognition is regained that the system begins a calibration cycle which includes articulation of the reload.This is considered to be what the customer experienced during the loading process.Based on these observations, it was concluded that the reload articulated on its own as reported by the customer due to cracked solder joints.A product enhancement has been initiated for the failure mode of uncontrolled articulation.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: IDRIVE ULTRA POWERED HANDLE 1
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT ; 2034925267
• MDR Report Key: 5404210
• MDR Text Key: 37337540
• Report Number: 1219930-2016-00077
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5F0315LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1