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

Model Number	VS101011P
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during trocar placement in a laparoscopic procedure, the cannula could not be placed through the radial sleeve.The issue was resolved by replacing the device with another trocar.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during trocar placement in a laparoscopic procedure, the cannula could not be placed through the radial sleeve.The trocar sleeve was damaged.The issue was resolved by replacing the device with another trocar.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the visual inspection of the returned product noted the radially expandable sleeve was split up the middle.The cannula was gouged at the distal end.The obturator was received inserted into the cannula.Prolonged insertion can cause the duckbill seal and circular seal to become stretched.The obturator was intact.Functional testing found that the returned product analysis performed functional testing; the obturator was removed and the seals were stretched out.The device failed an air leak test.The product was shipped back with the obturator inserted in the cannula and therefore the length of time it was inserted during shipment may have also resulted in the stretched seals.It was reported that the the insertion through the port was difficult and the trocar was damaged.The reported issues were confirmed.This issue may occur when contact is made with a surgical device during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use special care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadve rtent damage to the seal.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22585919
• Report Number: 9612501-2025-01986
• Device Sequence Number: 18476844
• Product Code: GCJ
• UDI-Device Identifier: 10884521082878
• UDI-Public: (01)10884521082878(17)300228(10)J5C4437Y(20)02
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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
• Device Lot Number: J5C4437Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 09/15/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/18/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown