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

Model Number INTB100

Device Problem Unintended Head Motion (1284)

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

Event Date 05/22/2017

Event Type  malfunction  

Event Description

According to the reporter, during the laparoscopic sigmoidectomy, the nurse inserted the battery to the handle as usual and the handle reacted and the handle indicator was flashed and illuminated normally.Then connected the adapter to the handle, the adapter indicator was flashed and illuminated, however the adapter began to rotate on its own and kept rotating for a few minutes.Replaced by another handle and adapter and the loading and firing was completed with no problem.No harm was caused to the patient.

• Brand Name: IDRIVE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6653139
• MDR Text Key: 77969981
• Report Number: 1219930-2017-05836
• Device Sequence Number: 1
• Product Code: GDW
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTB100
• Device Catalogue Number: INTB100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• 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