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

Model Number 173016

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 04/22/2019

Event Type  malfunction  

Event Description

The scrub tech could not load the suture into the endo stitch device because it would not "pull down to load suture" per instructions.The device was removed from the sterile field and a new device was opened.Device involved was saved and will be returned to the manufacturer for failure analysis.Manufacturer response for endoscopic tissue approximation device, endo stitch (per site reporter).The manufacturer was notified and the device will be returned for failure analysis.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 8631571
• MDR Text Key: 145829331
• Report Number: 8631571
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8L1401EY
• 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: 05/03/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 126