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

Model Number 173016

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

An endo stitch was opened to the sterile field at the start of the procedure.The surgeon complained that the device "was not working correctly" and requested another device.Per surgeon, the device was "sticking" or not opening and closing properly.A second endo stitch was opened to the sterile field.This device became stuck closed inside of the patient's abdomen.The device was removed from the abdomen and the vaginal cuff was closed in a different fashion.Both devices were saved in a biohazard bag and sent to clinical engineering.There were no visible defects other than the mentioned "sticking".The devices will be returned to the manufacturer for failure analysis, and no harm came to the patient in this case.Per site reporter: devices will be returned to manufacturer for failure analysis.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7540135
• MDR Text Key: 109117714
• Report Number: 7540135
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008
• Combination Product (y/n): N
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: 1303498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 98