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

Model Number HEMOPRO2 ADAPTOR

Device Problem Intermittent Continuity (1121)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (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 an endoscopic vein harvesting procedure using hemopro2 adaptor.They concerned about intermittent energy delivery during evh procedure.Isolated problem to adapter cable and replaced with a spare cable from second or setup.They reported no further issues with intermittent energy delivery during evh after switching to new adapter cable.No patient injury reported.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: g4, g7, h2, h3, h6, h10.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period sept 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.Testing of actual/suspected device & testing of raw/starting materials: (10 & 4105/213/67) : the device was returned to the factory for evaluation on 08/18/2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.Only the hp2 adaptor was returned for evaluation.Signs of clinical use and no evidence of blood was observed.There were no physical or visual defects observed on the adaptor.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident to a reference device.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.Based on the returned condition of the device, the reported failure "intermittent continuity" was not confirmed.This is a reusable oem device; therefore, a lot history/serial number review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

• Brand Name: HEMOPRO2 ADAPTOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12409908
• MDR Text Key: 271698305
• Report Number: 2242352-2021-00717
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: 08/18/2021
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 113