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

Model Number	179775P
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during laparoscopic choledocholithotomy, device was not used due to deformed part.It was difficult to set in the outer cylinder.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.The visual inspection noted; the threaded anchor, obturator, insufflation port and envelope seal all appeared intact.The cannula was not received.An air leak test could not be performed due to the missing cannula.All other components functioned properly.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.

• Brand Name: BLUNTPORT PLUS
• Common Device Name: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7126609
• Report Number: 9612501-2017-06790
• Device Sequence Number: 1210308
• Product Code: GDH
• UDI-Device Identifier: 10884521081161
• UDI-Public: 10884521081161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 12/27/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/27/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1