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

Model Number	MCVS550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
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 during vein harvesting, the head of dissector separated from the body during dissection.The dissector head broke off in the patient, but was immediately removed when they found it.No broken piece remained in the patient.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 may 03, 2021.¿ upon further investigation of the reported event, the following information is new and/or changed: device availability - added date returned to manufacturer.Date received by manufacturer.Indication that this is a follow-up report.Follow-up due to additional information.Device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information.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.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).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, 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 affected sample was inspected upon receipt to confirm that the dissector had separated.There were no signs of damage to the device.A representative retention sample was inspected to confirm no anomalies with the device.It is possible that adhesive agent peels off due to the effects of force on the device.Also, when the device is forcefully squeezed into the target area, adhesive agent peels off.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH, ENDOSCOPIC VEIN
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11759572
• Report Number: 1124841-2021-00097
• Device Sequence Number: 19956268
• Product Code: GCJ
• UDI-Device Identifier: 00699753018945
• UDI-Public: (01)00699753018945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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: 06/30/2021
• Device Model Number: MCVS550
• Device Catalogue Number: N/A
• Device Lot Number: 87K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 06/24/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/25/2021
• 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