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	Injury (2348)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting procedure, the scope was blurry as result they proceed without the scope and converted the procedure to open vein harvesting.Product was changed out.Procedure was completed successfully.
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 july 12, 2018.(b)(4).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 most likely root cause for this failure is, the product was either dropped or inadvertently struck by an object or excessive force was exerted on the endoscope shaft; this could deflect the shaft and lead to the alteration of the internal lens system.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: 7683633
• Report Number: 1124841-2018-00139
• Device Sequence Number: 1398938
• Product Code: GCJ
• UDI-Device Identifier: 00699753023222
• UDI-Public: (01)00699753023222
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MCENDO550R
• Device Catalogue Number: N/A
• Device Lot Number: 749623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention