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 05/29/2015

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable 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 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.(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.The rubber insulation that connects to the connector was broken.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, extension cable and reference power supply.The device failed the pre-cautery test; it provided intermittent energy to the device.Based upon the evaluation results, the reported complaint was confirmed for "intermittent/failed to deliver energy".A lot history search is not applicable because this is a reusable, non-serialized oem device for which the lot number was not provided to us.A ship history is not likely to identify the correct lot for the reported device.(b)(4).

Event Description

Additional information: the product is returning.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: EXTENSION CABLE
• Manufacturer (Section D): DATASCOPE CORP.; wayne NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4877816
• MDR Text Key: 6261582
• Report Number: 2242352-2015-00522
• Device Sequence Number: 0
• Product Code: KNS
• Reporter Country Code: US
• PMA/PMN Number: K101274
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-VH-4030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• 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