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

Model Number 173016

Device Problems Break (1069); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

The endo stitch handle lever that transfers the needle from side to side snapped off.The needle was not dislodged.The endo stitch handle was withdrawn, and the needle accounted for.A new endo stitch handle was opened.The defective one was removed from service.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12540321
• MDR Text Key: 273650248
• Report Number: 12540321
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J1D0030EY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA