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)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that the endoscope was blurry.It is unknown when this event occurred, and if the surgery was completed successfully.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.There was no delay in the procedure, the product was changed out with no harm and no 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: 4648- insufficient information.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.
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 june 30, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (adverse event problem 2199, 10, 3224, 3259, 19).Health effect - impact code: 2199 - no health consequence or impact.Type of investigation: 10 - testing of actual/suspected device.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.
Event or Problem Description
New information received indicates that the surgery was completed successfully.*no consequence or impact to patient.

• 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: 17237744
• Report Number: 1124841-2023-00161
• Device Sequence Number: 17943808
• Product Code: GCJ
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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
• Operator of Device: Other
• Device Model Number: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown