MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 176645

Device Problem Failure to Align (2522)

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

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)(4) program.Three complaints were received during this report period.Of these, (b)(4) were not returned for evaluation.(b)(4) has an investigation which is currently pending.All 3 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 3 malfunction events which are associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented.These reports were received from various sources.Patient information was not confirmed for these 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: 5830369
• MDR Text Key: 51513826
• Report Number: 2647580-2016-00444
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Number of Events Reported: 3
• 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: 176645
• Device Catalogue Number: 176645
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1