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

Model Number	VSP550EX
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, 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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that there was some matter/material that gummed up the cutter blades that caused the cutter to stop working.It is unknown when the problem occurred or if there was a delay.*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 july 6, 2018.(b)(4).Terumo has not received the device for evaluation; therefore, 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.
Event or Problem Description
Additional information was received indicating that the event occurred during vein harvesting procedure with a slight delay.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was a dissector; however, the reported failure mode is for a harvester.Since the actual sample was not returned for evaluation, a thorough investigation could not be performed and definitive root cause cannot be determined for this event.The manufacturing records were reviewed for the affected unit product code/lot number, no anomalies noted related to the issue during the manufacturing process.It is likely that the event was caused by customer technique.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS, EVH
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7666981
• Report Number: 1124841-2018-00132
• Device Sequence Number: 1040654
• Product Code: GCJ
• UDI-Device Identifier: 00699753022966
• UDI-Public: (01)00699753022966
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 7XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 07/24/2018; 08/22/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 07/18/2018; 08/09/2018; 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1