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

Model Number 176630B

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Exemption number e1999001.6 devices evaluated, 4 devices not evaluated.Device codes: 2984, 2921, 2976, 3273, 1212 result codes: 3243, 213, 3233 conclusion codes: 11, 61, 71.Of the 10 events being reported, 3 events were determined to be the result of misapplication by the user, 3 events had no device failure, and 4 events had no device returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

This report summarizes 10 malfunction events reported between january 1, 2018 and march 31, 2018.1 event associated with the unintentional separation of the device and/or its components from something to which it is connected or attached.3 events associated with the use of the device in terms of user experiencing difficulty opening and closing the device, even if the operation is being performed according to labeled instructions for use.1 event associated with an undesired material change in shape or property caused by external forces.5 events associated with device mechanical functioning of machinery, moving parts or tools of the device being changed or modified.

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were detected.During functional testing, the device fired properly, but did not have tactile feedback while firing.The instrument was disassembled and the latch component was found to be broken.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.The root cause of the observed condition was determined to be a result of a manufacturing activity and a product enhancement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO CLIP III
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 7470365
• MDR Text Key: 106955717
• Report Number: 9612501-2018-00882
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: K071406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 176630B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1