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

Model Number	VS101512P
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one photograph of a device.The photo depicts the distal end of the expandable sleeve.The end is frayed, also there is a trocar inserted through the sleeve, the end of the trocar is gouged.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 condition.Replication of the gouged cannula tip may occur if the device is mishandled or handled roughly during 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.
Event or Problem Description
According to the reporter, during a robotic hysterectomy procedure, the surgeon misaligned the trocar and pierced the sleeve on the side.A piece of the cannula broke off and fell into the patient's cavity but was retrieved by a grasper.They replaced the sleeve to re-enter the abdomen.No patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: the distal end of the expandable sleeve.The end is frayed, also there is a trocar inserted through the sleeve, the end of the trocar is gouged.The obturator appeared intact.A functional evaluation found that the device 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.Replication of the gouged cannula tip may occur if the device is mishandled or handled roughly during 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.

• 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: 8113924
• Report Number: 9612501-2018-02127
• Device Sequence Number: 11142108
• Product Code: GCJ
• UDI-Device Identifier: 10884521082854
• UDI-Public: 10884521082854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 07/31/2023
• Device Model Number: VS101512P
• Device Catalogue Number: VS101512P
• Device Lot Number: J8G0643X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR