MAUDE Adverse Event Report: COVIDIEN ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION

Catalog Number 173016

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

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

Event Date 12/26/2018

Event Type  malfunction  

Event Description

Initially, the endo stitch device did load correctly.The suture was off, so it only loaded on one side.We fixed this and loaded it correctly, but then the device would not toggle.The green handles to toggle felt more stiff than usual.Also, the spikes on the end of the tips of the device were only partially retracting and not every time it toggled.A new device was opened to complete procedure.Per hospital, the manufacturer provided return tracking number and shipping container after numerous reminder calls.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 8304307
• MDR Text Key: 134988588
• Report Number: 8304307
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2019

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: Health Professional
• Device Catalogue Number: 173016
• Device Lot Number: J8D2128EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Weight: 85