MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC 7MM EXTENDED LENGTH ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	VH-1111
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that 7mm extended length endoscope was reported as having a cloudy lens and being old.No patient harm.The issue occured in sterile process department.
Additional Manufacturer Narrative
(b)(4).The device was not returned to maquet cardiac surgery for investigation; therefore, no evaluation could be performed.It is not possible to confirm the reported complaint.Reported serial # (b)(6).A lot history search is not applicable because this is a reusable, oem device.Due to the age of the device, a c of c is not readily available on-site.

• Brand Name: 7MM EXTENDED LENGTH ENDOSCOPE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 24925278
• Report Number: 2242352-2026-0000289
• Device Sequence Number: 10276417
• Product Code: GCJ
• UDI-Device Identifier: 00607567700802
• UDI-Public: (01)00607567700802
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K014250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: VH-1111
• Device Catalogue Number: VH-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO.
• Patient Sex: Unknown