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

Model Number	VS100712P
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was diagnosed with a pneumothorax and brought to the operating room for a video-assisted thorascopic surgery (vats).During the procedure before closing, it was noted that an irregular yet oval-shaped piece of plastic port measuring approximately 2.5 x 4 millimeters had broken off the distal tip of the instrument.A tiny piece measuring approximately 1 millimeter was located and extracted from the chest wall.The wound was inspected with retractors layer by layer, then the chest was irrigated and periscapular wounds with saline.The inspection process was repeated, but no plastic was found.The field was inspected as well.The incision was then inspected with a sterile covered linear ultrasound probe, but the user could not identify any overt chest wall foreign body.The wound was re-irrigated and the chest wall was inspected layer by layer with the thoracoscope.Considering the risks associated with additional time under anesthesia, the surgeon proceeded with the completion of the operation.
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.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, a5, 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The first image depicts the obturator inserted into the cannula.The distal end of the cannula is gouged with a piece d disengaged.The second image depicts the top of the obturator.It was reported that a patient was diagnosed with a pneumothorax and brought to the operating room for a video-assisted thorascopic surgery (vats).During the procedure, before closing, it was noted that an irregular yet oval-shaped piece of plastic port measuring approximately 2.5 x 4 millimeters had broken off the distal tip of the instrument.A tiny piece measuring approximately 1 millimeter was located and extracted from the chest wall.The wound was inspected with retractors layer by layer, then the chest was irrigated and pericapsular wounds with saline.The inspection process was repeated, but no plastic was found.The field was inspected as well.The incision was then inspected with a sterile covered linear ultrasound probe, but the user could not identify any overt chest wall foreign body.The wound was re-irrigated and the chest wall was inspected layer by layer with the thoracoscope.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 23671825
• Report Number: 9612501-2025-03146
• Device Sequence Number: 9761435
• Product Code: GCJ
• UDI-Device Identifier: 10884521082823
• UDI-Public: (01)10884521082823(17)300831(10)J5J3680Y(20)02
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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: VS100712P
• Device Catalogue Number: VS100712P
• Device Lot Number: J5J3680Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 02/05/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/04/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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 Age: 15 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White