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 Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	11/19/2019
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the endoscope was blurry.The product was changed out.It is unknown whether there was blood loss, whether the surgery was completed successfully or if there was any patient effect.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.
Event or Problem Description
New information received that the surgery was completed successfully with no blood loss or patient injury.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accordance with applicable regulations and as indicated by terumo cardiovascular systems in the initial report submitted.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 2692, 10, 3331, 3224, 19).Patient code: 2692 no known impact or consequence to patient.Method code #1: 10 testing of actual/suspected device.Method code #2: 3331 analysis of production records.Results code: 3224 optical problem identified.Conclusions code: 19 cause traced to user.A visual observation of the internal components using a monocular was conducted to check the performance of the endoscope.It was discovered that there was a crack on one of the internal lenses which resulted in a blurry visual field.The possible causes which may produce this failure; the product was either dropped or inadvertently struck by an object or an excessive force was exerted on the endoscope shaft; this could deflect the shaft and lead to the alteration of the internal lens system.The labeling for the device stresses the importance of how fragile the device is and instructs the user to handle the product with extreme care to prevent damage to the device.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
• MDR Report Key: 9433068
• Report Number: 1124841-2019-00327
• Device Sequence Number: 16705021
• Product Code: GCJ
• UDI-Device Identifier: 00699753023222
• UDI-Public: (01)00699753023222
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 800028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1