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

Model Number 173016

Device Problems Failure to Disconnect (2541); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

The endostitch did not release the stitch properly.

• 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: 14786855
• MDR Text Key: 295251523
• Report Number: 14786855
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J0L014EY
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White