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

Model Number	VH-1111
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (b)(4).Event site name exceeded character limitations: (b)(6) hospital.
Event or Problem Description
The hospital reported that the black eye piece on the proximal end of scope of the 7mm extended length endoscope is loose.This was noticed in the sterile process department when connecting to the new camara.This incident did not occur during the procedure.There was no delay, and no patient harm as there was no patient involvement.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 04/09/2026.An investigation was conducted on 04/09/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact endoscope.The black eyepiece was observed to be attached to the base of endoscope and was not loose.An image quality inspection was performed with an endoscopic video imaging system.The endoscope was able to be attached to a reference light source with no physical or visual difficulties observed.A clear image was able to be obtained.Based on the returned condition of the device as well as the evaluation results, the reported failure "detachment of device or device component¿ was not confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.
Event or Problem Description
N/a.

• 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: 24922818
• Report Number: 2242352-2026-0000285
• Device Sequence Number: 21144348
• Product Code: GCJ
• UDI-Device Identifier: 00607567700802
• UDI-Public: (01)00607567700802
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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