MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB, OUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3200-W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic saphenous vein harvesting procedure, the handle of the bisector opened up by itself and a portion of the handle dropped on the floor.Another vv7 bisector was used and procedure completed with no complication.There was no adverse event.
Additional Manufacturer Narrative
Trackwise id 792750.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).The device was returned to the factory for evaluation on 03/27/2023.Photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.The handle of the device was observed to be detached and separated from each other.There were no other visual defects observed.A visual inspection was conducted on 08/30/2023.No signs of clinical use and no evidence of blood was observed as the device was returned inside the product packaging box.The handle of the device was observed to be detached and separated from the harvesting device.No other visual defects were observed.Based on the photographic evaluation as well as the investigation results, the reported failure "break" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 3000269859 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.
Additional Manufacturer Narrative
Trackwise # (b)(4), updated section: b4, g4, g7, h2, h6, h11 corrected section: h10- problem id corrected photographs were provided by the account.A photographic evaluation was conducted.The device was observed inside the opened product packaging box.Signs of clinical use and no evidence of blood was observed.The handle of the device was observed to be detached and separated from each other.There were no other visual defects observed.The device was returned to the factory for evaluation on (b)(6), 2023.A visual inspection was conducted on (b)(6), 2023.The device was returned outside the product packaging box.Signs of clinical use and no evidence of blood were observed.The handle of the device was observed to be detached and separated from the harvesting device.No other visual defects were observed.Based on the photographic evaluation as well as the investigation results, the reported failure "break" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.

• Brand Name: VASOVIEW 7 XB, OUS
• 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: 16686187
• Report Number: 2242352-2023-00284
• Device Sequence Number: 15482767
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 09/28/2024
• Device Model Number: VH-3200-W
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 3000269859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 09/28/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 09/15/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose