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

Model Number	MCENDO550
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting procedure, the scope was blurry.As per the subsidiary, when the surgical assistant started to dissect the veins, he found out that the scope was blurry.He cannot proceed with the vein harvesting and needed to convert the procedure to a skipping method, which leads to the delay of procedure for approximately 15 minutes.No known health consequences or impact to patient.Product was not changed out.Procedure completed successfully.
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.H6: component code: 866 - lenses, health effect - impact code: 4630 - modified surgical procedure, 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
Blurry scope.
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 october 13, 2023.The returned sample was visually inspected for damage and looked through the endoscope directly to read some print matter.The internal components was then inspected using a monocular and 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: ENDOSCOPE 5.5MM
• 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: 17933555
• Report Number: 1124841-2023-00244
• Device Sequence Number: 15056913
• Product Code: GCJ
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: 800816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian