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

Model Number 179775P

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/14/2017

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic assisted vaginal hysterectomy (lavh), the valve disengaged.They could not inflate the abdomen.The event occurred during the procedure but the product was not used for patient.The procedure was completed with another device.The status of the patient is no problem.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted; the port seal was received without the cannula and the insufflation port was disengaged.The condition of the device 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; therefore, a device history record will not be performed.Replication of the disengaged valve 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.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: 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6943997
• MDR Text Key: 89824689
• Report Number: 9612501-2017-06393
• Device Sequence Number: 1
• Product Code: GDH
• UDI-Device Identifier: 10884521081161
• UDI-Public: 10884521081161
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 179775P
• Device Catalogue Number: 179775P
• Device Lot Number: J7A1320X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• 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