MAUDE Adverse Event Report: COVIDIEN POLYSORB O ES-9 SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 170052

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Tip portion of suture needle broke off / retained in patient.Fda safety report id # (b)(4).

• Brand Name: POLYSORB O ES-9 SUTURE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11737215
• MDR Text Key: 248152696
• Report Number: MW5101015
• Device Sequence Number: 1
• Product Code: OCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170052
• Device Catalogue Number: 170052
• Device Lot Number: J0H3011Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• 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 Age: 62 YR