MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BLUNTPORT PLUS; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 179775P

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic cholecystectomy, the lower seal part disengaged from the device.The status of the patient was fine.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) received one device.The visual inspection noted the threaded anchor was received.The gasket for the threaded anchor was cut and disengaged.The obturator was not received.The trocar, envelope seal and circular seal appeared intact.The condition in which was received precludes functional testing.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.Replication of the cut in the circular seals may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy, the lower seal part disengaged from the device.The procedure was completed with another device.The status of the patient was reported as fine.

• Brand Name: BLUNTPORT PLUS
• Type of Device: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 7448844
• MDR Text Key: 106143177
• Report Number: 9612501-2018-00808
• Device Sequence Number: 1
• Product Code: GDH
• UDI-Device Identifier: 20884521081168
• UDI-Public: 20884521081168
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903419
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179775P
• Device Catalogue Number: 179775P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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