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

Model Number 176630B

Device Problems Detachment Of Device Component (1104); Fail-Safe Problem (2936)

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

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopy-assisted distal gastrectomy procedure.The surgeon was unable to squeeze the handle even though the clips still remained.The surgeon did not know whether the color of the clip changed.The surgical time was extended by less than 30 min.The part fell into the patient's cavity and could not be retrieved.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no visual abnormalities noted during the pmv examination.The clip counter was no longer active and there were no clips in the shaft.The device was received fully fired, and a functional test could not be performed because the device was engaged in the end of firing safety interlock.In addition, each device was inspected during manufacturing to confirm the presence of a full clip complement.Note that the information for use brochure which accompanies each product shipment cautions the user such as the counter fewer devices will have three blue clips to serve as a visual indicator that the user is approaching the end of the clip stack.When the first blue clip was seen, there were two additional clips remaining in the device.A safety interlock feature will prevent the handle from being squeezed and the empty jaw from closing once the last three clips have been fired.Furthermore; please be assured that each tube sub assembly was inspected during manufacturing to confirm full clip complement.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.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.

Event Description

According to the reporter, during laparoscopy-assisted distal gastrectomy procedure, the surgeon was unable to squeeze the handle e ven though the clips still remained.The surgeon did not know whether the color of the clip changed.The surgical time was extended by less than 30 min.The part fell into the patient's cavity and could not be retrieved.The procedure was completed with another device.

• 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: 7424854
• MDR Text Key: 105262141
• Report Number: 9612501-2018-00725
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20884521047263
• UDI-Public: 20884521047263
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 176630B
• Device Catalogue Number: 176630B
• Device Lot Number: J7F0476X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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
• Patient Outcome(s): Other