MAUDE Adverse Event Report: COVIDIEN ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL; LARYNGOSCOPE, ENDOSCOPE

Model Number 173050G

Device Problems Material Separation (1562); Material Deformation (2976)

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

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Procedure: laparoscopic surgery for prostate cancer.According to the reporter: when the shaft was inserted into the abdominal cavity, the distal end of the ring was separated when push out the pouch.Then it became malformed.Surgeon retrieved it and the rubber which was connected with the ring.Specimen was put into the bag, so this product was able to use for the patient.Operating time not extended.No tissue damage or bleeding.There was no additional tissue resection.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) conducted an evaluation of one device opened by the account.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) conducted an evaluation of one endo catch gold 10mm specimen pouch intl sealed.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, and an evaluation of the returned device.The bag was detached and not received.The string was cut, and there was no plastic bag remnant on the metal ring.The metal ring was intact.The plunger and metal ring advanced and retracted properly.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
• Type of Device: LARYNGOSCOPE, ENDOSCOPE
• 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: 4787046
• MDR Text Key: 5801146
• Report Number: 9612501-2015-00254
• 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,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J3L0834X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1