MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; QUANTUM SMART OCCLUDER - LEFT HAND

Model Number	51-000022-00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned and an investigation is ongoing.
Event or Problem Description
This issue relates to an occluder opening twice during surgery without request.The device is being returned and an investigation is ongoing into this problem.Although, there was no patient harm or delay to surgery.This event is deemed reportable by spectrum medical.
Additional Manufacturer Narrative
The device was returned to spectrum medical.During the visual inspection, blood was found inside the module.Blood was also detected on the bobbin housing, preventing the bobbin from being removed as usual.Additionally, blood and debris were found on the lead screw.Blood contamination was identified inside the sap connection as well as within the sensor connection port.Damage was observed on the occluder housing, indicating that it had been cleaned with an abrasive solution, which caused surface deterioration.The occluder was disassembled, and all internal parts and components were inspected.Liquid ingress and contamination were found inside the module.Based on the above findings, the presence of blood and debris caused the module malfunction.The contamination prevented the occluder from completing a full occlusion, as the mechanism was obstructed and unable to achieve full closure.The device was assessed as beyond economical repair.It is recommended to place the unit in a position that prevents any liquid ingress during use.Root cause was determined to be component fault.
Event or Problem Description
This issue relates to an occluder opening twice during surgery without request.The device is being returned and an investigation is ongoing into this problem.Although, there was no patient harm or delay to surgery.This event is deemed reportable by spectrum medical.

• Brand Name: QUANTUM
• Common Device Name: QUANTUM SMART OCCLUDER - LEFT HAND
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24244558
• Report Number: 3006073153-2026-00013
• Device Sequence Number: 21247047
• Product Code: DTQ
• UDI-Device Identifier: 05060434420732
• UDI-Public: 05060434420732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 51-000022-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown