MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (OUS) VH-3000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEWHEMPRO (OUS) VH-3000
Medical Device Problem Codes	Peeled/Delaminated (1454); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro (ous) vh-3000 jaw was found to be chipped and scratched during preparation.Used another set and finished the surgery.No patient involvement.
Additional Manufacturer Narrative
Corrected section: h3: device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: g4, g7, h2, h3, h6, h10 analysis of production : (3331/213/67) the device history records review concluded that 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.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2020 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 /213/67).The device was returned to the factory for evaluation on 11/03/2021.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be intact.No visual defects were observed.The gray silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.No peeling or scratched material was observed in the photographs.An investigation was conducted on 11/08/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be intact, no visual defects were observed.The gray silicone insulation on both the cold and hot jaws was observed to be intact, no peeling or scratches were observed.Based on the returned condition of the device, the reported failures "peeled; jaw" and " scratched material" was not confirmed.
Event or Problem Description
N/a.

• Brand Name: VASOVIEWHEMPRO (OUS) VH-3000
• 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
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12643652
• Report Number: 2242352-2021-00839
• Device Sequence Number: 4379872
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2021

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: 03/01/2022
• Device Model Number: VASOVIEWHEMPRO (OUS) VH-3000
• Device Catalogue Number: C-VH-3000-W
• Device Lot Number: 25156710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 12/10/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/22/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown