MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION REFURBISHED ENDOSCOPE 5.5M; LAPAROSCOPE, GENERAL

Model Number	MCENDO550R
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting, the endoscope had a cloudy image.As per the subsidiary, there was a delay in continuing the surgery because the surgeon needs the vein out before he can complete the surgical procedure.The surgery was completed successfully but they need to abort the endoscopic vein harvest and revert to an open procedure.To resolve the issue, they wiped it, re-white balanced, and changed the camera set.There was an unknown minutes of delay.There was a 75 ml blood loss.
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.For this reason, terumo references evaluation conclusion code 11.Component code: 866 - lenses.Health effect ¿ impact code #1: 4604 - delay to treatment/therapy.Health effect ¿ impact code #2: 4624 - surgical intervention.Health effect ¿ impact code #3: 4614 - serious injury/illness/impairment.Health effect ¿ clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 3001 - optical problem.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Event or Problem Description
Cloudy image.
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 09, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 3224, 3259, 19).Type of investigation #1: 10- testing of actual/ suspected device.Type of investigation #2: 3331- analysis of production records.Investigation findings #1: 3224 - optical problem identified.Investigation findings #2: 3259 - improper physical structure.Investigation conclusions: 19- cause traced to user.The affected sample was inspected upon receipt and a visual observation of the internal components using a monocular was conducted.It was discovered that there was a crack on one of the internal lenses which resulted in a blurry visual field.Improper handling caused the internal lens to break.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: REFURBISHED ENDOSCOPE 5.5M
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16897321
• Report Number: 1124841-2023-00111
• Device Sequence Number: 6163295
• Product Code: GCJ
• UDI-Device Identifier: 00699753023222
• UDI-Public: (01)00699753023222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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
• Device Model Number: MCENDO550R
• Device Catalogue Number: N/A
• Device Lot Number: 800375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown