MAUDE Adverse Event Report: COVIDIEN ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL; SINGLE USE SPECIMEN RETRIEVAL PRODUCT

Model Number 173050G

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

Procedure: total prostatectomy assisted by surgical robot.According to the reporter: after the specimen was caught in the bag and a doctor pulled the string, it was found that the metal ring got detached and the string was broken.The bag then could not be closed to retrieve the specimen.A new one was opened to complete the case with no problem.There was no patient harm and the patient's current status is good.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 04/06/2015.

• Brand Name: ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
• Type of Device: SINGLE USE SPECIMEN RETRIEVAL PRODUCT
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4559302
• MDR Text Key: 5560266
• Report Number: 9612501-2015-00116
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K922123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J4F0013MX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1