MAUDE Adverse Event Report: COVIDIEN ENDO CATCH* II 15MM SPECIMEN POUCH; LARYNGOSCOPE, ENDOSCOPE

Model Number 173049

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a lap nephrectomy, the "cinching" string did not work properly - the bag pulled away.The bad partially detached from the ring.To correct this condition, a new device was opened.This did not affect the patient.

Manufacturer Narrative

(b)(4).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, and an evaluation of the returned device.The reported condition for this incident was that the bag detached prematurely.The instrument was received with the bag detached and not received.There was plastic remnant on the ring and the ring was intact.The pull ring was not received.The plunger and metal ring advanced and retracted properly.Visual and functional testing of the returned product confirmed the product met quality release specifications that were tested regarding the reported conditions.Based on the product analysis, the failure was not confirmed to be attributed to the reported event.A review of the current historical complaint data reveals no trend for a device related failure for this condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• 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: 5790807
• MDR Text Key: 49429644
• Report Number: 9612501-2016-00276
• Device Sequence Number: 1
• Product Code: GCI
• UDI-Device Identifier: 10884523000948
• UDI-Public: (01)10884523000948(17)210228(10)J6B1968X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 173049
• Device Catalogue Number: 173049
• Device Lot Number: J6B1968X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1