MAUDE Adverse Event Report: COVIDIEN ENDO CATCH 12; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CATCH12

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

While pulling endocatch out of pt the specimen bag ripped along the seam.Bag inspected and all parts were accounted for surgical site checked to ensure no retained bag in place.Procedure: left thoracoscopy (video assisted thoracic surgery) with left upper lobectomy.Op note: i put the specimen in a specimen retrieval bag and 7th interspace anterior working port.Initially, i was unable to get the specimen out of the chest and used a rib spreader to gently spread the ribs.Fda safety report id# (b)(4).

• Brand Name: ENDO CATCH 12
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9823530
• MDR Text Key: 183345051
• Report Number: MW5093683
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CATCH12
• Device Catalogue Number: CATCH12
• Device Lot Number: C2101117G
• 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: 70 YR
• Patient Weight: 79