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

Model Number 173050G

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Tracking no: (b)(4).(b)(4).

Event Description

According to the reporter, during a lap chole, the bag did not close.Metal rim would not retract/broke.No patient injury or ill-effects.No medical intervention required.No reinforcement material used.No unanticipated tissue loss, tissue damage or bleeding.No extension to surgical time required.Nothing fell in the surgical cavity.Patient current status reported as stable.The device will be returned for evaluation.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) concurrently with sustaining engineering led an evaluation of received one device opened by the account.The 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 instrument was received with the bag disengaged and not received.No plastic remnant was noted on the ring.The black shrink tube was stretched and broken on the ring.The plunger and metal ring advanced and retracted properly.A review of the device history record indicates this device lot number/serial number was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur when an obstruction is introduced inside the metal ring.An obstruction can occur when an instrument, extraneous materials, or the cinched bag itself interferes with the retraction of the ring.In this case, the black shrink tube fails during retraction, but the black shrink tube remnant remains on the ring.The average force required to replicate condition has been measured at 14 lbs.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.(b)(4).

• 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: 5210805
• MDR Text Key: 31021338
• Report Number: 9612501-2015-00688
• Device Sequence Number: 1
• Product Code: GCI
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J5E0724MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1