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

Model Number VSP550EX

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

Patient Problems Blood Loss (2597); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that during vein harvesting procedure, the dissecting piece would not hold co2 pressure causing visualization issues.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.There was an unknown time of delay.

Event Description

Additional information received that the product was changed out, procedure completed successfully with minimal blood loss.Patient is doing well.Additionally, the pressure used for the insufflator was at 12 with flow rate of 10.They modified the settings during the case by attempting to go up on flow to 12.They used co2 cylinder, and verified the valve was open and the cylinder was full.They also used a disposable co2 tubing with no damaged found, and the tubing comes with a filter.There was no flow once the co2 being hooked up to the dissector.

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 december 14, 2020.  upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem); d11 (added concomitant medical products); g4 (date received by manufacturer) ; g7 (indication that this is a follow-up report) ; h2 (follow-up due to additional information) ; h6 (event problem and evaluation codes 2597, 11).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).D4 (additional device information - added exp date).D8 (added device serviced by a third party).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 525, 2199, 4604, 4582, 1184, 11, 3331, 4114, 3221, 4315).Component code: 525 - tube: health effect - impact code #1: 2199 - no health consequences or impact.Health effect - impact code #2: 4604 - delay to treatment/ therapy.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1184 - display or visual feedback problem.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation; therefore, a thorough investigation could not be conducted.All units from the same lot were found to pass production testing for the insufflation system.100% of production is subjected to testing.An insufflation test was conducted on a retention sample by connecting a syringe to the luer connector and no anomalies were found.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

Additional information received that, patient is not infectious.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.  upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (device evaluation anticipated by manufacturer - a third follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 213, 67).Type of investigation: 10 - testing of actual/suspected device.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The affected sample was inspected upon receipt to confirm a gap at the nose cone of the dissector.The dissector was sent to the supplier for investigation and a scar was issued to the supplier to investigate the situation with the dissector having a gap at the base of the nose cone.Following investigation at the supplier, containment, correction and corrective actions were implemented to prevent recurrence mis-assembly of the dissector and of the test equipment failure.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS, WITH RADIAL
• Type of Device: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11004660
• MDR Text Key: 247556408
• Report Number: 1124841-2020-00280
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (y/n): N
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 01K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STRYKER