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

Model Number	21-345
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively, two devices sparked and caught fire.It was noted that all devices from the same lot number have been pulled.There was no patient involvement.
Additional Manufacturer Narrative
D10 concomitant product: 21-345, 21-345 clearify visualization system, (lot# d4m1729y).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: b5, d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the device noted the foam body was torn near the power button.The valve was not opened.The surfactant was gone.Functional testing found that the tactile inspection of the power switch confirmed that the switch was fully activated.The device was dismantled; the foam body was torn to expose internal components.The battery was tested for voltage capacity and the device batteries were not drained.Brown stains on the inside of the foam body and near the seal were observed.It was reported that instrument sparked.The reported issue was confirmed.The most likely cause was traced to design.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, pre-operatively, two devices sparked and caught fire.It was noted that when the device was turned on, it emitted a funny smell and failed to warm the scope as expected.While the foam portion of the device became very warm, the area where the scope was inserted remained cool and the device's light was not illuminated.Additionally, it was also noted that all devices from the same lot number have been pulled.There was no patient involvement.

• Brand Name: CLEARIFY
• 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: 21751287
• Report Number: 9612501-2025-00919
• Device Sequence Number: 9822041
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: 10884521213562
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K062779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: D4M1729Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown