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

Model Number	B5SHF
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	04/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the laparoscopic appendectomy procedure the obturator/trocar broke.Also, the physician was using an atraumatic instrument to grasp the tip of the trocar to assist with insertion.During this stage, three small fragments of tip fell into abdomen that were subsequently retrieved using suction-irrigation device.To complete the procedure, a second trocar was inserted.There was no harm caused to the patient.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of the device.The visual inspection of the returned product noted that the distal end of the obturator had gouges in it.The trocar was not received.Pmv performed functional testing: the obturator blade was actuated and fired through the test media.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 gouges on the distal end of the obturator may occur when mishandled during clinical application.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: VERSAONE
• 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: 6553480
• Report Number: 9612501-2017-05464
• Device Sequence Number: 533325
• Product Code: GCJ
• UDI-Device Identifier: 20884521539812
• UDI-Public: 20884521539812
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K151548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2017

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: 08/31/2021
• Device Model Number: B5SHF
• Device Catalogue Number: B5SHF
• Device Lot Number: J6H0058X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 06/28/2017; 06/28/2017; 08/15/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/26/2017; 09/07/2017; 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR