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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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: 4580- insufficient information.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
The user facility reported to terumo cardiovascular that endoscope has dark image.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.The event related information is not available.
Event or Problem Description
Dark 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 november 3, 2023.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) ; h4 (device manufacture date); h6 (identification of evaluation codes 10, 3331, 3224, 3259, 19, 133).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 #1: 19 - cause traced to user.Investigation conclusions #2: 133 - end of life problem identified.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 it was discovered that there was a crack on one of the internal lenses which resulted in a dark visual field.It is also noted that this device was used approximately 11 months past its expiration date.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: 18067317
• Report Number: 1124841-2023-00254
• Device Sequence Number: 7815452
• Product Code: GCJ
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/21/2023

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 Expiration Date: 11/18/2022
• Device Model Number: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: 629690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2012
• 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
• Patient Sex: Unknown