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

Model Number	VASOVIEW 7 XB BISECTOR (US)
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise 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 using vasoview 7 xb bisector (us), the c-ring was in the field of view.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (us), the c-ring was in the field of view.They always keep the c-ring extended and have utilized the cannula rotation technique previously but it's unclear if it was used in this situation.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
H6 correction: patient code changed to code 4582.Internal complaint number: (b)(4).The lot # 25152234 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.The device was returned to the factory for evaluation on 01/25/2021.An investigation was conducted on 02/17/2021.A visual inspection was conducted.Both the harvesting device as well as the cannula was returned for evaluation, signs of clinical use and slight evidence of blood was observed on the intact c-ring.There were no visual defects observed on the cannula or the harvesting device.A reference endoscope was inserted into the cannula with no physical or visual difficulties.The harvesting device was then inserted into the cannula with no physical or visual difficulties.A mechanical evaluation was conducted.The c-ring on the cannula was retracted and extended with no physical or visual difficulties.The c-ring was observed to be in its normal position after extension of the c-ring.Based on the returned condition of the device, the reported failure "poor quality image" was not confirmed.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11279257
• Report Number: 2242352-2021-00105
• Device Sequence Number: 2688424
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 06/22/2022
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: 25152234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1