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

Model Number	VSR100005
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
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 laparoscopic excision of lesion of uterus, it was not too smooth when inserting the dilator into the outer sheath of the device.The surgical time was extended by less than 30 min.The procedure was completed with another device.The status of the patient was reported as no problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the protective sheath of the radially expandable sleeve was cut.The trocar and envelope seal appeared intact.The condition in which the device was received precludes functional testing.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 cut in 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.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: 7469387
• Report Number: 9612501-2018-00877
• Device Sequence Number: 18863970
• Product Code: GCJ
• UDI-Device Identifier: 10884521084209
• UDI-Public: 10884521084209
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 10/31/2022
• Device Model Number: VSR100005
• Device Catalogue Number: VSR100005
• Device Lot Number: J7K1067X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1