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

Model Number	179078P
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2018
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, during laparoscopic coelioscopy procedure, after the introduction of the trocar, she realized that the trocar broke a triangular tip was missing.The broken end was found in the patient's abdomen.To complete the case, they removed the tip from the abdomen and replaced the trocar with a other device.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two photographs of a device.The first photograph depicts the device being help during a surgical procedure.The second photograph depicts the tip of the disengaged device being retrieved during a surgical procedure.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 disengaged 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 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: VERSAPORT PLUS
• 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: 7436621
• Report Number: 9612501-2018-00754
• Device Sequence Number: 1007135
• Product Code: GCJ
• UDI-Device Identifier: 10884521082663
• UDI-Public: 10884521082663
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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 Model Number: 179078P
• Device Catalogue Number: 179078P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1