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	07/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, a piece of the vasoview hemopro vh-3500 silicone jaw became dislodged.A small piece which coats the wire came loose at the very end of the case and dropped in the leg.The piece wasn't retrieved.They couldn¿t find the piece of detached silicone.No additional incisions were required.They were working on a setting of 3 and the tips were loaded up.There was no delay to the case, and they didn't open a new kit.No harm.Per photo provided by the complainant, it is observed that the harvesting tool and c-ring devices were in the harvesting tunnel.It is observed the jaws of the device are closed, and a piece of the silicone is detached between the jaws.The c-ring is observed to be intact.
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)" to "(b)(4)." the device was returned to the factory for evaluation on 07/15/2024.An investigation was conducted on 10/29/2024.Photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.The jaws were observed in a closed state.There were no visual defects observed on the intact heater wire.Peeling of the inside of the jaw was observed.No other visual defects observed.An investigation was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the gray cold jaw insulation.The gray hot jaw silicone insulation was observed to be intact.The heater wire was observed to be intact.The heater wire was raised to observe the inside of the hot jaw insulation.Peeling was observed.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 #3000402378 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.
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: 19850521
• Report Number: 2242352-2024-00857
• Device Sequence Number: 17744642
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000402378(17)250617
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician Assistant
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000402378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 92 KG