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

Model Number	NONB12SHF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a transabdominal preperitoneal (tapp) procedure.Upon opening the packaging, the head of the obturator disengaged.The event occurred during the procedure but the product was not used on the patient.The procedure was completed with another device.There was no patient harm.The status of the patient is no problem.
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 top of the obturator was disengaged.The device was received with the obturator inserted into the cannula.Pmv performed functional testing; the device failed an air leak test.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 disengaged obturator top 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.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: 6547615
• Report Number: 9612501-2017-05444
• Device Sequence Number: 628075
• Product Code: GCJ
• UDI-Device Identifier: 10884521546905
• UDI-Public: 10884521546905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 02/28/2021
• Device Model Number: NONB12SHF
• Device Catalogue Number: NONB12SHF
• Device Lot Number: J6B0543X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1