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

Model Number	MCVS550HVJ
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting, the c02 was not insufflated.The device was not used and surgical incision was performed as the vein was thin.Subsequently, the surgery was completed successfully.Co2 value was set at 15mmhg (pressure).Co2 flow rate was set to 2 l/min and the pressure to 15 mmhg.
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 march 10, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacture.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.The affected sample was inspected upon receipt with no visual anomalies noted.The sample was then setup with an endoscope and a plug to test for gross leaks in the insufflation system.There were no gross leaks or apparent anomalies with the insufflation system on the harvester.A representative retention sample was inspected with no visual anomalies noted.The sample was then setup with an endoscope and a plug to test for gross leaks in the insufflation system.There were no gross leaks or apparent anomalies with the insufflation system on the harvester.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: 11456932
• Report Number: 1124841-2021-00052
• Device Sequence Number: 3524031
• 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): 04/28/2021

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: 08/31/2021
• Device Model Number: MCVS550HVJ
• Device Catalogue Number: N/A
• Device Lot Number: 89K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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