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

Model Number 173016

Device Problems Break (1069); Sticking (1597)

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

Event Date 01/22/2018

Event Type  malfunction  

Event Description

During the procedure, an endostitch was being used.At one point, the stitch became stuck in the device.While trying to retrieve it, the needle broke in half.The device was removed from the field and replaced with a new device.The pieces of the needle were retrieved with no harm to the patient and the procedure was completed as planned.Upon receipt of the device, clinical engineering also noted the black button on the handle of the device was broken.It is unclear whether this was the cause of, or the result of, the device becoming jammed.Images are included in the attachments section of this report.A return kit will be issued 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: 7240643
• MDR Text Key: 98991732
• Report Number: 7240643
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2022
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J7K1923EX
• 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: 01/30/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• 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: 63 YR
• Patient Weight: 130