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

Model Number	179775P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior a laparoscopic cholecystectomy procedure, nurse noted that the packing inside the metallic grip was out of position.Not used.The procedure was completed with another device.
Additional Manufacturer Narrative
Based on review of the file, this report was updated from a malfunction to a non-reportable event.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: 6979651
• Report Number: 9612501-2017-06496
• Device Sequence Number: 648857
• 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,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: 11/30/2021
• Device Model Number: 179775P
• Device Catalogue Number: 179775P
• Device Lot Number: J6L2606X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1