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

Model Number	UNVCA5SHF
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
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 right hemicolectomy, at the time of setup, the obturator became unable to be removed, so they stopped using the device.Both device collected had their obturator difficult to be removed.The event occurred during the procedure but the product was not used for patient.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned products noted: the circular seals were cut.The duckbill seals, trocars and cannula appeared intact.A functional evaluation found that the devices passed an air leak test.An ethicon ligamax and a stryker strykeflow ii were used to test for resistance by inserting and removing into the cannula.No resistance was noted.The cannula tip was checked with a.233 pin gauge and was in spec.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Additionally, the investigation detected an unreported condition of cut in the circular seals that has no relationship to the reported condition.No further actions have been deemed necessary at this time.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 PR 0101 ; DO 0101
• MDR Report Key: 9847309
• Report Number: 2647580-2020-00981
• Device Sequence Number: 2421192
• Product Code: GCJ
• UDI-Device Identifier: 30884521215416
• UDI-Public: 30884521215416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: UNVCA5SHF
• Device Catalogue Number: UNVCA5SHF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1