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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (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.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh- 3000, the silicone protective layer of the electrocoagulation forceps fell off without causing any harm to the patient.Nothing fell into the patient.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was not returned to maquet cardiac surgery for investigation.However, photographs were provided by the account.A visual inspection of the photographic evidence was conducted on 21aug2020.Signs of clinical use and evidence of blood were observed.Tissue and charred material was observed on the jaws.Signs of clinical use and evidence of blood were observed.The boot from the cold jaw was completely detached exposing the cold jaw.The silicone insulation on hot jaw was melted, charred and whitish in color.Based on the photographic inspection, the reported failure "peeled; jaw" is confirmed and analyzed failure "thermal decomposition of device" was also confirmed.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh- 3000, the silicone protective layer of the electrocoagulation forceps fell off without causing any harm to the patient.Nothing fell into the patient.The hospital did not report any patient effects.

• 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: 10400822
• Report Number: 2242352-2020-00705
• Device Sequence Number: 3093682
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 11/19/2020
• Device Model Number: VASOVIEWHEMPRO (OUS) VH-3000
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 25149059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 73