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

Model Number	NONB15STF
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
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
According to the reporter, intra-operatively, the seal disengaged into the cavity.Air or gas leaked from the seal.The seal was retrieved from the cavity with graspers.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted on the image that the disengaged circular seal on a monitor during a surgical procedure and the surgeon held the cannula with a view of the duckbill seal, seal housing and disengaged circular seal.The visual inspection of the returned product noted that the circular seal was disengaged.Functional testing found that the device duckbill seal passed an air leak test.It was reported that the seal disengaged to patient cavity and there was an air leakage.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when contact is made with a surgical instrument 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: VERSAONE
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19668305
• Report Number: 9612501-2024-01621
• Device Sequence Number: 14237137
• Product Code: GCJ
• UDI-Device Identifier: 10884521548091
• UDI-Public: 10884521548091
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K160230
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 09/30/2025
• Device Model Number: NONB15STF
• Device Catalogue Number: NONB15STF
• Device Lot Number: J3K2113Y
• 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: 06/08/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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