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

Model Number	MCENDO550R
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting procedure, they noticed a foggy scope.It is unknown if the product malfunction caused or contributed to an injury.Terumo continues an attempt to gain more information regarding this event from the user facility.Product was changed out.Procedure was completed successfully with 2 minutes delay.
Event or Problem Description
New information received.The product did not malfunction cause or contribute to an injury, even if temporary, or death.
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 april 8, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) h6: health effect - impact code: 2199 - no health consequences or impact.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: h6 (identification of evaluation codes 10, 3331, 3224, 19).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 3224 - optical problem identified.Investigation conclusions: 19 - cause traced to user.Upon evaluation of the device the complaint was confirmed.The complaint sample was returned and visually inspected.A monocular was used to inspect the device and it was discovered that there was a crack on one of the internal lenses which resulted in a blurry visual field.A review of the device history record revealed no anomalies.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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14058255
• Report Number: 1124841-2022-00084
• Device Sequence Number: 4621500
• Product Code: GCJ
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2022

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: Health Professional
• Device Model Number: MCENDO550R
• Device Catalogue Number: N/A
• Device Lot Number: 800361
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 06/01/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/07/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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