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

Model Number	NONB15LGF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
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 instrument exchange in a laparoscopic sleeve gastrectomy, the seal disengaged.The internal blue seal fell into patient cavity.The surgeon located the seal and took out a new trocar to finish the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the obturator appeared intact.The circular seal was disengaged.The cannula, trocar and envelope seal appeared intact.The obturator was received inserted into the cannula.Prolonged insertion can cause the envelope seal to become stretched.A functional evaluation found that 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.Replication of the disengaged circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed 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.
Event or Problem Description
According to the reporter, during instrument exchange in a laparoscopic sleeve gastrectomy, the seal disengaged.The internal blue seal fell into patient cavity.The surgeon located the seal and took out a new trocar to finish the case.There was no patient injury.

• 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: 8000520
• Report Number: 9612501-2018-01869
• Device Sequence Number: 1531208
• Product Code: GCJ
• UDI-Device Identifier: 10884521548107
• UDI-Public: 10884521548107
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 03/31/2020
• Device Model Number: NONB15LGF
• Device Catalogue Number: NONB15LGF
• Device Lot Number: J8C2085X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1