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

Model Number VH-1111

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during repossessing, 7mm extended length endoscope s/n (b)(6) had a crack in the lens, cleaning it does not work.This issue was found by the sterilization team during the sterilization process and was brought to their attention.No patient effects reported, as there was no patient involvement in this situation.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 07/17/2023.An investigation was conducted on 08/01/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the endoscope.An image quality inspection was performed with an endoscopic video imaging system.A clear image was able to be obtained.The image was observed to be clear with no cracks observed.Based on the results of the evaluation, the reported failure "crack " 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 lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

N/a.

• Brand Name: 7MM EXTENDED LENGTH ENDOSCOPE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17431289
• MDR Text Key: 320170382
• Report Number: 2242352-2023-00625
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607567700802
• UDI-Public: 00607567700802
• Combination Product (y/n): N
• PMA/PMN Number: K014250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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
• Device Operator: 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: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: N/A.