MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CATCH GOLD; LARYNGOSCOPE, ENDOSCOPE

Model Number 173050G

Device Problem Component Missing (2306)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one endo catch gold 10mm pouch.The visual inspection of the returned product noted that the bag was received retracted inside the tubing, the bag was completely folded and partially separated from the ring, and uncinched.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The conditions noted suggest that the gold ring and suture line were not pulled, thus indicating that the bag did not detach as a result of this action.Replication of these conditions may occur if instead, the plunger is retracted after bag deployment, causing bag detachment.A secondary condition of damaged shaft was noted.Replication of the damaged shaft may be due to rough handling of the device.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the device was not used.The bag was missing when the device was removed from the packaging.The device did not grasp properly.The handles did not bind.To resolve the issue they took another device.There was no patient injury.

• Brand Name: ENDO CATCH GOLD
• Type of Device: LARYNGOSCOPE, ENDOSCOPE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6766738
• MDR Text Key: 81803842
• Report Number: 9612501-2017-05893
• Device Sequence Number: 1
• Product Code: GCI
• UDI-Device Identifier: 20884523000952
• UDI-Public: 20884523000952
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J5L1456MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1