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

Model Number	ONB5STF2C
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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 laparoscopic cholecystectomy, the device had a damaged seal.When inserting the device into sleeve, a small piece of plastic blue valve shaved off and had to be retrieved from patient.They opened another device to complete the case.There was no patient injury.
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 two devices.The visual inspection noted: the circular seals, trocars and envelope seals appeared intact.The obturator was received and appeared intact.A functional evaluation found that the devices passed 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 7706415
• Report Number: 9612501-2018-01334
• Device Sequence Number: 1269782
• Product Code: GCJ
• UDI-Device Identifier: 10884521657656
• UDI-Public: 10884521657656
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2018

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: 02/28/2023
• Device Model Number: ONB5STF2C
• Device Catalogue Number: ONB5STF2C
• Device Lot Number: J8B1270JX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/14/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1