MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4020

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(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

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 adaptor prior to the patient arriving in the or.The equipment was tested and it was determined that the hemopro generator adapter was not functioning.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot /serial history review was not applicable.A serial/lot number was not provided and the specific product serial/lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The device was returned to the factory for evaluation.Signs of clinical use were observed, though no signs of blood were present.There were no visible defects detected.To test the adaptor's ability to produce energy, it was connected to a reference cable, and reference power supply at level 3.0.Once connected to a reference cable and reference power supply, the reference cable was then connected to a reference hemopro 2 device.The toggle on the hemopro 2 device was manipulated several times, opening and closing the jaws, with no noticeable power or heat being produced once the jaws were closed.The adaptor was then disconnected from the reference cable and reference power supply, and a reference adaptor was then connected to the reference cable and power supply.The reference cable was then connected to the hemopro 2 device, and once the toggle was manipulated, power and heat was immediately produced upon the closing of the jaws.Based on the returned condition of the device, the reported failure "failure to deliver energy" is confirmed.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 adaptor prior to the patient arriving in the operation room.The equipment was tested and it was determined that the hemopro generator adapter was not functioning.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 adaptor prior to the patient arriving in the or.The equipment was tested and it was determined that the hemopro generator adapter was not functioning.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HEMOPRO2 ADAPTOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7431068
• MDR Text Key: 105664479
• Report Number: 2242352-2018-00343
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

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 Catalogue Number: C-VH-4020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 06/14/2018; 07/09/2018
• Supplement Dates FDA Received: 06/22/2018; 07/09/2018
• 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: N
• Patient Sequence Number: 1