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

Model Number	VASOVIEWHEMPRO (OUS) VH-3000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 preparation for an endoscopic vein harvesting procedure using vasoview hemopro (ous) vh-3000, the wire on the jaw was defected when opened (jaw was bent).It was discovered before usage.A replacement device was used to complete the procedure.No patient involvement.
Additional Manufacturer Narrative
Updated sections: g4, g7, h2, h3, h6, h10 trackwise # (b)(4).The device was returned to the factory on 09/28/2020.Photographs were provided by the account.Upon photographic inspection, the harvesting device was out of the plastic protective shell and plastic covering and on an exam table.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be twisted back from the tip to the center of the hot jaw.No other visual defects were observed on the jaws in the photograph provided.An investigation was concluded on 10/21/2020.Signs of clinical use and no evidence of blood was observed.The harvesting device was returned outside its plastic protective shell and plastic covering, both of which were not returned for evaluation.The heater wire on the harvesting device was observed to be bent and twisted away from the base of the hot jaw with detachment at the tip.The heater wire was observed to be attached at the base of the hot jaw.The gray silicone insulation on both the cold and hot jaws were observed to be intact.No visual defects were observed.Based on the investigation results, the reported failure "material twisted/ bent wire¿ is deemed confirmed.The dhr.Shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro (ous) vh-3000, the wire on the jaw was defected when opened (jaw was bent).It was discovered before usage.A replacement device was used to complete the procedure.No patient involvement.

• 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 07470
• MDR Report Key: 10610846
• Report Number: 2242352-2020-00840
• Device Sequence Number: 19127299
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 02/13/2021
• Device Model Number: VASOVIEWHEMPRO (OUS) VH-3000
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 25150265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1