MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; 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	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro vh-3500 jaws cracked but remained intact and did not dislodge.The power was set to 3.Nothing was left in patient.A new device was used to complete the procedure with no issues.There was no delay.There was no patient harm.Per photo provided by the complainant, it is observed a piece of the silicone is broken off from the jaws of the device.There is evidence of blood observed on the device.
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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Corrected sections: d4--unique identifier (udi) # corrected from (b)(4).D4-- catalogue # and model # corrected from "vh-4000" to "vh-3500".The device was returned to the factory for evaluation on 09/16/2024.A photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.The gray silicone insulation on the hot jaw was observed to be intact.The heater wire was observed to be intact.The gray silicone insulation on the tip of the cold jaw was observed to be peeled and detached from the cold jaw, exposing the cold metal jaw tip.No other visual defects were observed.An investigation was conducted on 10/03/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the gray intact hot jaw insulation and the intact heater wire.The gray silicone insulation on the cold jaw was observed to be peeled and detached from the cold jaw, exposing the cold metal jaw tip.The detached silicone was not returned for evaluation.No other visual defect.Based on the photographic evaluation, as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000380475 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.

• Brand Name: VASOVIEW HEMOPRO 2
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 20301270
• Report Number: 2242352-2024-0001065
• Device Sequence Number: 8686258
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000380475(17)260315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 03/15/2026
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000380475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG