MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 174213

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4) complaint was received during this report period.(b)(4) was determined to be misapplication.One reported device is labeled for single use.None of the devices were reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 1 malfunction event which are issue associated with undesired damage or breakage of those materials used in device construction.No patient information was confirmed.

• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave.; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5612545
• MDR Text Key: 44552827
• Report Number: 2647580-2016-00198
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 174213
• Device Catalogue Number: 174213
• Type of Device Usage: N
• Patient Sequence Number: 1