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

Model Number 176619

Device Problem Difficult to Insert (1316)

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

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the event occurred at the first firing in thoraco/lobectomy procedure.When inserting and removing the clip through the metal reuse thoraco port, the tip of the clip shaft rubbed against the metal port.A part of the clip cover might partially peel off or deviated.It didn't fall down.The procedure was completed with another device.The status of the patient was reported as no problem.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with sixteen remaining clips.A portion of the shrink wrap was missing mid way on the shaft assembly.The instrument was applied to appropriate test media for functional evaluation.The instrument was found to cycle without binding.Clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.In addition, when the cartridge was empty, the interlock engaged 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.Replication of the reported condition may occur when interaction between the instrument shaft and trocar system may result in a tear of the shrink wrap during device insertion or removal.Additionally, please be sure to avoid shrink wrap contact with sharps or cautery devices during the application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No fu rther actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO CLIP
• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8015196
• MDR Text Key: 125328670
• Report Number: 9612501-2018-01893
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057838
• UDI-Public: 10884521057838
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954435
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 176619
• Device Catalogue Number: 176619
• Device Lot Number: J7M0499CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2017
• 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