MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	179094F
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
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, intra-operatively, the protector blue plastic part that was at the tip of the trocar device stayed inside, while pulling back and it separated from the tip part of the trocar.The device replaced to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the distal end of the bladed trocar was disengaged.The disengaged piece was received.The cannula was not received.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the disengaged bladed trocar tip may occur if the device is mishandled or handled roughly during application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a lap.Cholecystectomy , the protector blue plastic part that was at the tip of the trocar device fell into the patient cavity, while pulling back and it separated from the tip part of the trocar.The piece that fell was retrieved.The device was replaced to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a lap.Cholecystectomy , the protector blue plastic part that was at the tip of the trocar device fell into the patient cavity, while pulling back and it separated from the tip part of the trocar.The device was replaced to complete the case.There was no patient injury.

• Brand Name: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7886042
• Report Number: 9612501-2018-01660
• Device Sequence Number: 2061205
• Product Code: GCJ
• UDI-Device Identifier: 20884521081274
• UDI-Public: 20884521081274
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2018

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: 01/31/2023
• Device Model Number: 179094F
• Device Catalogue Number: 179094F
• Device Lot Number: J8A2009X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/21/2018; 11/27/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/16/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1