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	Foreign Body In Patient (2687)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 small piece of rubber from tip of jaw came off.No patient harm other than the fact that a tiny piece of rubber was left in the leg.It was not retrievable following several attempts with the jaws of the hemapro (too small).No added incisions.Finished case using same device.Time added to case was not measured but it did occur.
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 an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 small piece of rubber from tip of jaw came off.No patient harm other than the fact that a tiny piece of rubber was left in the leg.It was not retrievable following several attempts with the jaws of the hemapro (too small).However, the piece was so small the harvester could not tell if it came out of the leg or not.The tunnel was irrigated several times.No added incisions.Finished case using same device.Time added to case was not measured but it did occur.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, b5, g3, g6.H2, h10.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,g3,g6,h2,h3,h6,h11.Corrected section: d4 udi#.The device was returned to the factory for evaluation on 07/26/2024.An investigation was conducted on 08/08/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.The heater wire was observed to be slightly flexed away from the base of the jaw but remained attached at the tip of the jaw, which can be attributed to clinical use.The gray silicone insulation of the cold jaw was observed to be intact with no visual defects.A thin strip of silicone insulation along the heater wire on the hot jaw was observe to be peeled and detached from the jaw.The detached silicone was not returned for evaluation.Based on the returned condition of the device and investigation results, the reported failure "peeled; jaw" was confirmed.The lot # 3000384902 history record review was completed.There was (01)ncmr, 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.
Event or Problem Description
N/a.

• 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: 19919494
• Report Number: 2242352-2024-00896
• Device Sequence Number: 12573767
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000384902(17)250404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000384902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 12/04/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/30/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown