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

Model Number	VH-3200
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during the middle of an endoscopic vein harvesting procedure, it was discovered that the vasoview 7 xb bisector (us) cannula slot for the light cord would not allow the scope to seat properly in place.The scope would not click into the cannula, and the c ring was visible the entire time.A new kit was opened to complete the case.Minor delay in completing the case.No patient injury.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 07/14/2023.An investigation was conducted on 08/01/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on either the harvesting device or the cannula.A mechanical evaluation was conducted.A reference endoscope was inserted into the cannula until it snapped into place with no visual difficulties observed.The harvesting device was then inserted into the cannula with no physical or visual difficulties observed.The blue toggle on the cannula was manipulated to retract and extend the intact c-ring.There were no visual difficulties observed.The blue toggle on the harvesting device was manipulated to retract and extend the cutter blade.There were no visual difficulties observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "fitting problem- endoscope" was not confirmed.The lot # 3000308060 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 7XB
• 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: 17324937
• Report Number: 2242352-2023-00578
• Device Sequence Number: 12334896
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K041981
• 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): 08/07/2023

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: 04/02/2025
• Device Model Number: VH-3200
• Device Catalogue Number: VH-3200
• Device Lot Number: 3000308060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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 Sex: Unknown