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

Model Number 173016

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

Portion of needle broke off in the patient intra-op; unable to find remaining portion of needle in patient; surgeons aware; patient was noted to have multiple areas of thicker tissue.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 14282601
• MDR Text Key: 290799468
• Report Number: MW5109496
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 173016
• Device Lot Number: J1J2273EY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White