MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP III; CLIP, IMPLANTABLE

Model Number 176630

Device Problems Retraction Problem (1536); Mechanics Altered (2984)

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

Event Date 09/12/2017

Event Type  malfunction  

Event Description

According to the reporter, after 5 or 6 firings were successful, surgeon could not load the device anymore.No patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially fired with five clips remaining.Visual inspection of the instrument noted that one of the jaw legs was out of position.The cam on the jaw leg was not aligned with the driver.Functionally, the jaw leg was reset by aligning the cam with the driver.The instrument was then applied to test media.The remaining clips loaded into the jaws, formed properly, released from the jaws and remained securely attached to test media.The interlock engaged after all clips were dispensed to prevent the jaws from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures; therefore, a device history record will not be performed.Replication of the disengaged jaw cam condition may occur when one of the jaws legs gets forcefully pulled outward away from the center line of the shaft.The noted jaw cam disengagement impedes functionality of the jaws, possibly resulting in clip malformation and/or difficulty removing the instrument from a trocar.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• 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: 6930407
• MDR Text Key: 89475073
• Report Number: 9612501-2017-06366
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057859
• UDI-Public: 20884521057859
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J7C1534X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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