MAUDE Adverse Event Report: COVIDIEN ENDOSTITCH; ENDOSCOPE AND/OR ACCESSORIES

Catalog Number 173016

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/29/2016

Event Type  malfunction  

Event Description

The device wouldn't open or close.

• Brand Name: ENDOSTITCH
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5935440
• MDR Text Key: 54203700
• Report Number: 5935440
• Device Sequence Number: 0
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 173016
• Device Lot Number: J6E0376X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 127