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

Model Number REF 173016

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

The doctor was doing a gastric bypass on the above patient, when the endo-stitch would not load properly.The needle kept coming off the endo-stitch device.I opened another endo-stitch device and the same thing happened.There was no harm to the patient.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 6240660
• MDR Text Key: 64450856
• Report Number: 6240660
• Device Sequence Number: 1
• Product Code: OCW
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2021
• Device Model Number: REF 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6J0213X
• 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: 11/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• 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: 26 YR