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

Model Number	VS101011P
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	08/20/2018
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 a laparo gyn, when piercing the abdominal wall, the tip of the access needle bent.Also, the covering the mesh part of the expandable sleeve was detached and dropped into the abdominal cavity, but was subsequently retrieved.The procedure was completed with another device.The surgical time was extended by less than 30 min.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 obturator was received.The trocar and cannula appeared intact.The envelope seal and circular seal appeared intact.The insufflation port appeared intact.The proximal end of the radially expandable sleeves was disengaged.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 disengaged top 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 caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during a laparo gyn, when piercing the abdominal wall, the tip of the access needle bent.Also, the covering the mesh part of the expandable sleeve was detached and dropped into the abdominal cavity, but was subsequently retrieved via forceps.The procedure was completed with another device.The surgical time was extended by less than 30 min.There was no patient harm.

• 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: 7856342
• Report Number: 9612501-2018-01602
• Device Sequence Number: 16535430
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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 Model Number: VS101011P
• Device Catalogue Number: VS101011P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1