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

Model Number 173050G

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering review of the product and an evaluation of the returned device.The instrument was not deployed.The gold pull ring was still seated in the handle.The handle was detached from the instrument.The plunger and metal ring could not be advanced and retracted properly.Engineering determined that the manufacturing personnel incorrectly assembled the blade and body assembly.An awareness training is in place.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.An awareness training was implemented.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter, during a lap chole, when surgeon tried to plunge the instrument to open the ring of the device, the shaft would not advance, the ring could not pop open.Another device was used without further consequences.Udi, gender, age and weight are not available.No patient injury or ill-effects.

• 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: 5806182
• MDR Text Key: 49903200
• Report Number: 9612501-2016-00305
• Device Sequence Number: 1
• Product Code: GCI
• UDI-Device Identifier: 20884523000952
• UDI-Public: (01)20884523000952(17)180930(10)J5J0988MX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K922123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J5J0988MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1