MAUDE Adverse Event Report: DATASCOPE CORP. HEMOPRO2 EXTENSION CABLE

Model Number C-VH-4030

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro extension cable and the adapter did not have power from the generator to the hemopro 2 device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).

Manufacturer Narrative

The device was returned to the factory for evaluation.The device showed no signs of clinical usage and no evidence of blood.A visual inspection was conducted.No defects were observed.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident.An electrical evaluation was performed.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2, reference adapter cable and reference power supply.The device passed the pre-cautery test.A polyfuse electrical test was performed with the same reference power supply, adapter cable and hemopro 2; the polyfuse successfully shut off power to the heater after prolonged periods of time and activated after the device cooled.Based upon the evaluation results, the reported complaint was not able to be confirmed.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Manufacturer (Section D): DATASCOPE CORP.; wayne NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4881562
• MDR Text Key: 6062173
• Report Number: 2242352-2015-00523
• Device Sequence Number: 0
• Product Code: KNS
• Reporter Country Code: US
• PMA/PMN Number: K043155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-VH-4030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1