MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3500
Medical Device Problem Codes	Mechanical Problem (1384); Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 bisector was not coming out of the device in the usual fashion and part of the device which is supposed to retract back into the device all the way was not doing so.
Additional Manufacturer Narrative
Tw 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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The lot # 3000379282 history record review was completed.There was a 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 failures.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW HEMOPRO
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19633464
• Report Number: 2242352-2024-00745
• Device Sequence Number: 18276591
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345(10)3000379282(17)250313
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: K153194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 03/13/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000379282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown