MAUDE Adverse Event Report: COVIDIEN 0 POLYSORB ENDOSTITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 170056

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2020

Event Type  Injury  

Event Description

While closing the vaginal cuff with the endostitch suturing device with a 0 polysorb suture (170050), the needle broke in 2 pieces.One section was removed with attached suture, the other segment was not found.Imaging was called to do a/p and lateral images.A tiny spec appeared on film and confirmed image.Endostitch suturing device (173016), lot#j9b0008ey, exp 1/31/2024; 0 polysorb endostitch (170056) lot# j9m2542y, exp: 11/30/2024; lot# j9d1628y, exp: 3/31/2024; lot# j9c2540y exp: 2/29/2024.Fda safety report id# (b)(4).

• Brand Name: 0 POLYSORB ENDOSTITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10658037
• MDR Text Key: 211060335
• Report Number: MW5097171
• Device Sequence Number: 2
• 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: 10/06/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 170056
• Device Catalogue Number: 170056
• Device Lot Number: J9M2542Y
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• 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: 45 YR
• Patient Weight: 64