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

Model Number	VS101011P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
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, intra-operatively, during laparoscopic excision of lesion of uterus, the plastic part of the expandable sleeve was found to be peeled and frayed.The fiber seemed to be exposed.To complete the case, they did nothing.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 the obturator was received inserted into the cannula.Prolonged insertion can cause the envelope seal to become stretched.The trocar and cannula appeared intact.The envelope seal and circular seal appeared intact.The insufflation port appeared intact.The distal end of the radially expandable sleeve was frayed.Pmv performed functional testing; 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.Analysis concluded there were no assembly component related failures.Replication of the frayed distal end of the radially expandable sleeve may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened, and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSASTEP PLUS
• 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: 7381487
• Report Number: 9612501-2018-00652
• Device Sequence Number: 13743383
• Product Code: GCJ
• UDI-Device Identifier: 20884521082875
• UDI-Public: 20884521082875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012539
• 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): 06/07/2018

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: 08/31/2022
• Device Model Number: VS101011P
• Device Catalogue Number: VS101011P
• Device Lot Number: J7H0776X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1