MAUDE Adverse Event Report: COVIDIEN LLC PROTRACK AUTO SUTURE FIXATION DEVICE; PROTRACTOR

Catalog Number REF 174006

Device Problem Component Falling (1105)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

While using an instrument called a protractor while dr (b)(6) using protractor to place abdominal mesh in and after firing it itjust fell apart in her hand.

• Brand Name: PROTRACK AUTO SUTURE FIXATION DEVICE
• Type of Device: PROTRACTOR
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 4540426
• MDR Text Key: 5508441
• Report Number: MW5040811
• Device Sequence Number: 1
• Product Code: OCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: REF 174006
• Device Lot Number: P4H0459X
• Other Device ID Number: (01) 10884521070400
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR