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

Model Number	VS100705
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/05/2019
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 pecto seal procedure, when the camera or grasper inserting in trocar, the seal was too tight.Instruments are very hard to insert.When instruments are retracted it was too tight and pull out the visa port through the incision on multiple occasions.Another trocar was used to complete the case.There was no patient injury.

• 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: 8827847
• Report Number: 9612501-2019-01456
• Device Sequence Number: 2399442
• Product Code: GCJ
• UDI-Device Identifier: 10884521082809
• UDI-Public: 10884521082809
• 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
• Report Date (Section B): 07/25/2019

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: 02/29/2024
• Device Model Number: VS100705
• Device Catalogue Number: VS100705
• Device Lot Number: J9C0117Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 54