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

Model Number 173016

Device Problem Device Slipped (1584)

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

Event Date 12/08/2019

Event Type  malfunction  

Event Description

Surgeon stated that the device would not lock and toggle would not stick.A new handpiece was opened to complete procedure.Manufacturer response for suturing device, covidien endo-stitch (per site reporter).After multiple reminder phone calls, manufacturer provided rga# and product return packaging.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9763942
• MDR Text Key: 181159840
• Report Number: 9763942
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J9F1512EY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 63