MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH HARVESTER; LAPAROSCOPE, GENERAL

Model Number	MCVS550HVJ
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting procedure, there was a failure in electrical continuity.It was replaced thrice but still failed; as a result, an open surgical procedure was performed.It is unknown if there was a delay in the procedure.The product was changed out.Procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on september 7, 2018.(b)(4).The three returned samples were visually inspected.One of the returned samples had blood within the insufflation tubing and the harvester rod was bent at the handle.No other visual anomalies were noted with any of the returned units.Electrical circuit testing was then conducted on the returned samples.Upon evaluation, they were all found to function within specification.A retention sample form the same product code and lot number combination was visually inspected.No anomalies noted anywhere on the device.Electrical circuit testing was then conducted on the retention sample, and was confirmed to function within specification.Possible root causes include foreign materials temporarily attaching to the active electrode during use, interrupting the electrical circuit, or when attempting to cauterize the vessel or capillary, they were not in contact with the ground electrode, causing the event.The reported event was not able to be replicated; therefore, the definitive root cause was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH HARVESTER
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7857511
• Report Number: 1124841-2018-00222
• Device Sequence Number: 13940664
• Product Code: GCJ
• UDI-Device Identifier: 00699753021075
• UDI-Public: (01)00699753021075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: MCVS550HVJ
• Device Catalogue Number: N/A
• Device Lot Number: 77K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention