MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-4030

Device Problem Intermittent Continuity (1121)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

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 Description

Related to (b)(4) the hospital reported that during an endoscopic vein harvesting procedure, hemopro 2 extension cable seems to be glitchy (works intermittently).

Event Description

Per acct mgr, complaint tw #: (b)(4) mfg report #2242352-2023-00469 is a duplicate of tw (b)(4)- mfg report #2242352-2023-00468.Therefore, complaint record will be cancelled.

Manufacturer Narrative

Per acct mgr, complaint tw # (b)(4) mfg report #2242352-2023-00469 is a duplicate of tw (b)(4) - mfg report #2242352-2023-00468.Therefore, complaint record will be cancelled.

• Brand Name: HEMOPRO 2 EXTENSION CABLE
• Type of Device: 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
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17083234
• MDR Text Key: 317739133
• Report Number: 2242352-2023-00469
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: 00607567700925
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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
• Device Operator: Health Professional
• Device Model Number: VH-4030
• Device Catalogue Number: VH-4030
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/08/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose