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

Model Number HEMOPRO2 EXTENSION CABLE

Device Problem Intermittent Continuity (1121)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

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

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable had intermittent power to hemopro device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable had intermittent power to hemopro device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

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.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.The device was returned to the factory for evaluation on (b)(6) 2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The extension cable was observed to be intact, with both collars attached to the cable.A mechanical evaluation was conducted using a reference adaptor, power supply and hemopro 2 device.The cable was able to be connected to the adaptor with no physical or visual difficulties.The reference harvesting device was attached to the cable with no physical or visual difficulties observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device did pass the pre-cautery test.The power supply emitted an audible beeping sound and the evh reference tool produced steam and heat.Based on the returned condition of the device and the results of the evaluation, the reported failure "intermittent continuity" was not confirmed.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11105678
• MDR Text Key: 224792434
• Report Number: 2242352-2021-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: 00607567700925
• 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: 12/28/2020

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: HEMOPRO2 EXTENSION CABLE
• Device Catalogue Number: VH-4030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1