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

Model Number	VS101505
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively during a laparoscopic gastric bypass, multiple different 5mm instruments were introduced and caught in the middle portion of the cannula.This only happened on the first 4-5 passes through the cannula and then it no longer occurred.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the trocar, cannula, circular and envelope seals appeared intact.The radially expandable sleeve was received.The obturator was received.A functional evaluation found that the device passed an air leak test.The cannula tip was checked with a 221.Pin gauge and was in spec.No resistance was noted.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: VERSASTEP
• 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: 7819319
• Report Number: 9612501-2018-01522
• Device Sequence Number: 11374224
• Product Code: GCJ
• UDI-Device Identifier: 20884521082868
• UDI-Public: 20884521082868
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012539
• 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
• Report Date (Section B): 12/05/2018

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: 04/30/2023
• Device Model Number: VS101505
• Device Catalogue Number: VS101505
• Device Lot Number: J8D1106X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1