MAUDE Adverse Event Report: COVIDIEN NS-3631 N-STER DISPOSABLE; LITE HANDLE COVER

Model Number 31159422

Device Problems Crack (1135); Split (2537)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with lite handle covers.The customer reports that the lite handle covers are cracking and splitting.

• Brand Name: NS-3631 N-STER DISPOSABLE
• Type of Device: LITE HANDLE COVER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5980054
• MDR Text Key: 55784615
• Report Number: 9612030-2016-00471
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016

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?: Yes
• Device Operator: No Information
• Device Model Number: 31159422
• Device Catalogue Number: 31159422
• Device Lot Number: 609036764X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 09/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1