MAUDE Adverse Event Report: COVIDIEN COVIDIENT ENDO STITCH AUTO SUTURE SUTURING DEVICE; ENDOSCOPIC TISSUE APPROXIMATE DEVICE

Catalog Number REF 173016

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Patient in surgery for laparoscopic hysterectomy.Rn attempting to load covidien endo stitch auto suture suturing device and it would not load.Rn tried new suture and it was still unable to load.Equipment taken out of service.Equipment never reached the patient.No patient harm.Fda safety report id # (b)(4).

• Brand Name: COVIDIENT ENDO STITCH AUTO SUTURE SUTURING DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATE DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9676965
• MDR Text Key: 178146411
• Report Number: MW5092803
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• 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: 02/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 173016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 37 YR
• Patient Weight: 88