MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN MEDTRONIC ENDOSTITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/08/2020

Event Type  Injury  

Event Description

Endostitch - when surgeon transferred needle to opposite side of endostitch the needle did not lock as designed.As a result the needle became dislodged in the tissue.The needle was easily visualized under direct laparoscopy (in use at the time) and was removed without further incident.Fda safety report id #(b)(4).

• Brand Name: MEDTRONIC ENDOSTITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): MEDTRONIC/COVIDIEN
• MDR Report Key: 10396486
• MDR Text Key: 202906469
• Report Number: MW5096036
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884621100008
• UDI-Public: 0110884621100008
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J0C1155EY
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 142