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

Model Number VSP550EX

Device Problem Defective Component (2292)

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

Event Date 08/15/2022

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.For this reason, terumo references evaluation conclusion code 11.(b)(4).Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during vein harvesting procedure, the endodoctor endoscope would not fully click into the dissector.It is unknown if there was a blood loss, terumo continues to attempt to gain more information regarding this event from the user facility.No health consequences or impact, product was not changed out, procedure completed successfully.

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 2, 2022.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added new information).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 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.

Event Description

New information received.There was a delay of around 5 minutes and no blood loss.

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: h6 (identification of evaluation codes 10, 11, 3331, 3259, 19).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 19 - cause traced to user.The returned sample was visually inspected upon receipt.It was confirmed that the clip inside the dissector handle was damaged.A retention sample from the same product code and lot number was obtained and visually inspected.No damage was noted to the clip inside the dissector handle.An endodoctor scope was able to be inserted and clipped in with no issues noted.The same scope was used to replicate the reported issue.As the scope was being inserted, it was twisted slightly causing the clip to become damaged.The root cause is determined to be user technique.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15350013
• MDR Text Key: 305594753
• Report Number: 1124841-2022-00149
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

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
• Device Operator: Other
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 1YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/05/2022; 10/27/2022
• Supplement Dates FDA Received: 09/23/2022; 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1