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

Model Number 173016

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

During a laproscopic repair of paraesophageal hernia with anterior lateral gastropexy during the use of the endo stitch, 1 of the needles dislodged deploying in the surrounding tissue.It was stuck in the tissue, did not remove and cause injury.The needle was retained.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7872086
• MDR Text Key: 120120330
• Report Number: 7872086
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8C1740EX
• 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: 09/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21535 DA