MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG IDRIVE ULTRA; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problems Unintended Head Motion (1284); Difficult to Open or Close (2921)

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

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: for the first firing for open gastroenterostomy , the nurse connected the reload to adapter with no problem, checked the jaws opening/closing and handed the device over to the surgeon.The surgeon pushed the blue button to close the jaws; however the device did not react.At the moment of releasing the blue button, even though the surgeon did not push the silver toggle, however the jaws were rotated.They replaced by another device and the procedure was completed.The status of the patient is with no problem.No adverse events reported.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation replicated the reported condition of uncontrolled rotation.When the device was opened it was determined that the two screws under the open/rotation silver switch were loose and not properly screwed in.The switch assembly was replaced and manipulated until one of the screws got stuck in the switch assembly causing the uncontrolled articulation.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a component error was identified during product analysis.The observed failure was caused by the two loose screws which were missed during the assembly process.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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 NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6709891
• MDR Text Key: 79897238
• Report Number: 1219930-2017-05988
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142794
• UDI-Public: 10884521142794
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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