MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 174233

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted under alternative summary reporting exemption (b)(4).This summary report is part of the (b)(6).Six complaints were received during this report period.Of these, 3 have investigations which are currently pending (b)(4).Three were determined to be misapplication (b)(4).All 6 reported devices are labeled for single use.None of the devices were reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 6 malfunction events which are associated with undesired damage or breakage of those materials used in device construction.These reports were received from various sources.Patient information was not confirmed for 6 events.

• 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: 5830320
• MDR Text Key: 51385064
• Report Number: 2647580-2016-00450
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 174233
• Device Catalogue Number: 174233
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1