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

Model Number	VASOVIEWHEMPRO (US) VH-3000
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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 using vasoview hempro (us) vh-3000, jaws were sheared when out of the package 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 preparation for an endoscopic vein harvesting procedure using vasoview hempro (us) vh-3000, jaws were sheared when out of the package a replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise #: (b)(4).The device was returned to the factory for evaluation on 10/15/2020.An investigation was conducted on 10/29/2020.While it was stated that the event was during preparation, signs of clinical use and evidence of blood and charred material was observed on the heater wire.The heater wire was observed to be slightly flexed away at the center of the hot jaw, with no detachment of the heater wire which indicates clinical use.The gray silicone insulation on the cold jaw was observed to be peeled away from the center of the cold jaw to the tip of the cold jaw exposing the metal portion of the cold jaw.The detached silicone insulation was not returned for evaluation.No other visual defect were observed.Based on the returned condition of the device, the reported failure "peeled jaw" was confirmed.The lot #: 25150502 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.

• Brand Name: VASOVIEWHEMPRO (US) VH-3000
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10678102
• Report Number: 2242352-2020-00889
• Device Sequence Number: 19489869
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• 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): 10/14/2020

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: 02/26/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25150502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1