MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ENDOSCOPE 5.5 MM STERILE, REUSABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	MCENDO550
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
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.For this reason, terumo references evaluation conclusion code 11.
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting there was a blurry image.As per the subsidiary, a visual inspection is done before the dissection.User can see the image clearly and start the procedure.The procedure run smoothly but towards the end of dissection, suddenly the image turn blur slowly.They take out the endoscope and wipe the lens but still blurry.They convert to open method for the vein harvesting.*no consequence or health impact to patient *there was a 30 minutes delay *product was not 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 january 17, 2025.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).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3221, 19).The sample was not returned; therefore, a direct investigation could not be performed.Past product complaints were reviewed for similar issues.The most likely root cause is 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.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.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 and device evaluation) h3 (device evaluated by manufacturer) h6 (identification of evaluation codes 10, 3224,19) the affected sample was returned for evaluation.It was visually inspected for damage and looked through the endoscope directly to read some print matter, and internal components using a monocular.It was discovered that there was a crack on one of the internal lenses which resulted in a blurry visual field.The evaluation of the returned unit was found that 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: ENDOSCOPE 5.5 MM STERILE, REUSABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 21180069
• Report Number: 1124841-2025-00004
• Device Sequence Number: 8546499
• Product Code: GEI
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952(11)230322
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K160206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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 Model Number: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: 800995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 02/20/2025; 03/26/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/14/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian