MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 2; STAPLE, IMPLANTABLE

Model Number IDRVULTRA2

Device Problems Unintended Arm Motion (1033); Difficult to Remove (1528)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a low anterior resection, the reload could not be removed from the adapter and it was articulating uncontrollably.There was no harm or injury to the patient.They opened another device to finish the case.The device was cleaned manually.No reinforcement material was used.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Device evaluation summary: post market vigilance (pmv) led an evaluation one endo gia adapter and one idrive ultra powered handle.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an engineering evaluation of the returned device.Microscopic evaluation revealed 2 cracked solder joints in the adapter.During functional testing, the handle tested satisfactorily.The reported conditions were not replicated during testing.Disassembly of the device revealed a bowed switch affecting the switch activation height.The lockout slider block also exhibited damage consistent with improper loading of the device by the user.Visual testing of the returned product confirmed the reported condition due to the bowed switch and cracked solder joints.Inconsistent reload recognition can be caused by a malfunctioning switch as a result of compromised solder joints.The root cause of the observed condition was determined to be a result of a manufacturing activity and a product enhancement has been initiated to prevent recurrence of this condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: IDRIVE ULTRA POWERED HANDLE 2
• 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 06473 ; 2034925267
• MDR Report Key: 5942355
• MDR Text Key: 54402749
• Report Number: 1219930-2016-00954
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Device Lot Number: N5E0783LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENDO GIA ADAPTER STANDARD