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

Model Number	MCENDO550R
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Insufficient Information (4580)
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 a broken scope, as it will not stay focus.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.No additional information will be provided.
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 february 6, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d1 (brand name - corrected).D9 (updated device availability).D4 (additional device information - corrected model number, unique identifier (udi).Number, and added expiration date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3224, 19).The affected sample was not returned for evaluation; therefore, a direct investigation could not be performed.Past product complaints were reviewed for similar issues and 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.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 3224, 19).The returned sample was visually inspected 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: 18654441
• Report Number: 1124841-2024-00018
• Device Sequence Number: 15231699
• Product Code: GCJ
• UDI-Device Identifier: 00699753023222
• UDI-Public: (01)00699753023222
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 05/09/2024

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: MCENDO550R
• Device Catalogue Number: N/A
• Device Lot Number: 806039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 04/26/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/07/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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