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

Model Number	UNVCA5SHF
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
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 a laparoscopic procedure, when the suction was pull out, it was stuck in the seal so everything had to be removed.The seal disengaged and there was no gas is coming oft of the pneumoperitoneum.To complete the procedure, took out the trocar and got a new one.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that an irrigating wand was received stuck in the cannula.The wand was jammed tightly into the cannula and could not be removed even under force.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 reported condition may occur when an incompatible device is used.The instructions for use ifu states," before endoscopic instruments and accessories from different manufactures are used, verify compatibility and ensure that electrical isolation or grounding is not compromised." the root cause of the observed damage was the product not being used as indicated which would have caused or contributed to the reported incident.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: 8717494
• Report Number: 9612501-2019-01202
• Device Sequence Number: 13922222
• Product Code: GCJ
• UDI-Device Identifier: 10884521546844
• UDI-Public: 10884521546844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112349
• 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
• Report Date (Section B): 08/22/2019

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: 10/31/2023
• Device Model Number: UNVCA5SHF
• Device Catalogue Number: UNVCA5SHF
• Device Lot Number: J8L1406JY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1