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

Model Number	VH-3500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id (b)(4).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 an endoscopic vessel harvesting procedure, vaso view hempro vh-3500 inner portion of the rubber cap broke off on the trocar of the btt.A new device was used to complete the procedure.There were no complications.
Additional Manufacturer Narrative
Tw # (b)(4).Corrected section: d4 udi#.The device was returned to the factory for evaluation on 08/20/2024.An investigation was conducted on 09/04/2024.A visual inspection was conducted.The btt body was not returned for evaluation.The scope seal as well as a gray circle piece was returned for evaluation.The gray circle piece was returned off the scope seal.No other visual defects were observed.An engineer evaluation was conducted.A piece of the short port seal 7mm scope (part number rm30498) broke off.See attached engineer evaluation memo.Based on the returned condition of the device as well as the evaluation results, the reported failure "break; seal" was confirmed.The lot # 3000392531 history record review was completed.There were 3 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.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• 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: 20076636
• Report Number: 2242352-2024-00971
• Device Sequence Number: 12365835
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000392531(17)260506
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K153194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 05/06/2026
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000392531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown