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 Codes	Burn(s) (1757); No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
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 an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, the darker grey plastic jaw that separated at the hinge point fell in the patient and they had to retrieve it from the leg.They were able to retrieve it endoscopically (the broken piece was retrieved by the device itself by the pa).On this incident the vein graft was burnt.There were no exposed wires and the silicone sheath was not compromised."no damage done to patient, all parts accounted for and replacement hemopro opened to field.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, the darker grey plastic jaw that separated at the hinge point fell in the patient and they had to retrieve it from the leg.They were able to retrieve it endoscopically.No damage done to patient or vein, all parts accounted for and replacement hemopro opened to field.
Additional Manufacturer Narrative
(b)(4).Corrected section: h6- corrected "patient codes".The device was returned to the factory for evaluation on 01/06/2021.An investigation was conducted on 02/12/2021.A visual inspection was conducted.Signs of clinical use, evidence of blood and charred tissue was observed on the heater wire.The gray silicone insulation on the cold jaw was observed to be peeled away from the middle of the cold jaw to the tip of the cold jaw, exposing the metal portion of the cold jaw.The peeled away silicone insulation was not returned for evaluation.Based on the returned condition of the device, the reported failure "peeled jaw" was confirmed.The lot # 25150454 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.
Additional Manufacturer Narrative
Correct b5 to reflect the corrected information.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, the darker grey plastic jaw that separated at the hinge point fell in the patient and they had to retrieve it from the leg.They were able to retrieve it endoscopically.No damage done to patient or vein, all parts accounted for and replacement hemopro opened to field.

• 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: 10937897
• Report Number: 2242352-2020-01061
• Device Sequence Number: 11560648
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25150454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 02/12/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/28/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention