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

Model Number HEMOPRO2 ADAPTOR

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(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 Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor, they had determined that the vh-4020 was processed through sterilization and causing intermittent power disturbances during vessel ligation.This was not done on a patient.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor, they had determined that the vh-4020 was processed through sterilization and causing intermittent power disturbances during vessel ligation.This was not done on a patient.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product 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 on 08dec2020.An investigation was conducted on 18dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was 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 as was performed per the instruction for use (ifu) with a reference hemopro 2, adapter cable and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced steam and heat during 5-second activations and shut off when the toggle was released.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.This adaptor was sterilized, when it is not supposed to be sterilized.Based on the returned condition of the device, there were no issues found with the product.

• Brand Name: HEMOPRO2 ADAPTOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11028183
• MDR Text Key: 222069034
• Report Number: 2242352-2020-01125
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: 00607567700918
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMOPRO2 ADAPTOR
• Device Catalogue Number: VH-4020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1