MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3500
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw 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 or Problem Description
The hospital reported that during preparation for an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 silicone tip of cutting device was partly detached right out of box.There was no patient involvement.Photos provided by the complainant show the jaws with the silicone peeling off one side.There is no evidence of blood.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).Updated sections: b-4, g-3, g-6, h-2, h-3,h-6, h-11.The device was returned to the factory for evaluation on 08/08/2024.Photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.The device was observed outside its product packaging.There were no visual defects observed on the heater wire or the intact gray silicone insulation on the hot jaw.The gray silicone insulation on the tip of the cold jaw was observed to be peeled back.No other visual defects were observed.An investigation was conducted on 08/21/2021.A visual inspection was conducted.The device was returned in its opened plastic carrier.Signs of clinical use were observed.Although the complaint was reported as an out of box failure, under microscopic inspection, evidence of blood was observed.There were no visual defects observed on the heater wire or the intact gray silicone insulation.The gray insulation on the cold jaw tip was observed to be peeled from the center of the cold jaw to the tip of the cold jaw.No other visual defects were observed.Based on the returned condition of the device as well as the photographic evaluation, the reported failure "peeled; delaminated;jaw" was confirmed.The lot # 3000398856 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

• Brand Name: VASOVIEW HEMOPRO
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• 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: 19998741
• Report Number: 2242352-2024-00936
• Device Sequence Number: 11855713
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K153194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 06/04/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000398856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/17/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown