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

Model Number	NB11STF
Medical Device Problem Codes	Detachment Of Device Component (1104); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a cholecystectomy, there was missing the obturator tip, the surgeon looked for the missing parts in the abdomen but nothing was found, at the end of surgery after taking out the cannula he found the missing parts inside the wound.The surgeon removed the pieces from the wound.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted; the obturator was broken at the distal end.A sample jar was received with 2 small fragments.The trocar was not received.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 broken obturator 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.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6499600
• Report Number: 9612501-2017-05359
• Device Sequence Number: 1659247
• Product Code: GCJ
• UDI-Device Identifier: 10884521075726
• UDI-Public: 10884521075726
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K081169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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: 07/31/2021
• Device Model Number: NB11STF
• Device Catalogue Number: NB11STF
• Device Lot Number: J6G1975X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 06/06/2017; 06/06/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 07/05/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR