MAUDE Adverse Event Report: MEDTRONIC ENDO STITCH 0 GRN 120 SURGIDAC

Model Number 173024

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Difficult to Insert (1316); Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 02/03/2017

Event Type  malfunction  

Event Description

The device was difficult to toggle, load and unload.There were sticking observed during the case with the needle falling off.Devices within same lot numbers taken off shelf and replaced by other medtronic products.

• Brand Name: ENDO STITCH 0 GRN 120 SURGIDAC
• Type of Device: ENDO STITCH 0 GRN 120 SURGIDAC
• Manufacturer (Section D): MEDTRONIC; wexford PA 15090
• MDR Report Key: 6345415
• MDR Text Key: 67960611
• Report Number: MW5067956
• Device Sequence Number: 1
• Product Code: OCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173024
• Device Lot Number: J6D0875X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ENDO STITCH SINGLE USE LOADING UNIT WITH ; SURGIDACA GREEN 48" ES-9 (SINGLE STITCH RELOAD)
• Patient Outcome(s): Other
• Patient Age: 88 YR