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

Model Number	MCENDO550R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 the endoscope was broken.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.Terumo continues to attempt to gain more information regarding this event from the user facility.
Event or Problem Description
New information received that the event occurred during setup, the product was changed out, no delay and procedure completed successfully with no patient effect.
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 december 6, 2019.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated description event or problem); d4 (additional device information - added lot number and expiration date); d5 (updated operator of device); d10 (device availability - added date returned to manufacturer); e1 (initial reporter - added reporter's name and updated address); e2 (updated health professional); e3 (updated occupation); g4 (date received by manufacturer) ; g7 (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 2645, 10, 3331, 3224, 3259, 19).Patient code: 2645 - no patient involvement; method code #1: 10 - testing of actual/suspected device; method code #2: 3331 - analysis of production records; results code #1: 3259 - improper physical structure; results code #2: 3224 - optical problem identified; conclusions code: 19 - cause traced to user.The actual sample was returned and was visually inspected for damage and looked through the endoscope directly to read some print matter.A visual observation 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 broken 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
• MDR Report Key: 9432904
• Report Number: 1124841-2019-00325
• Device Sequence Number: 10879988
• Product Code: GCJ
• UDI-Device Identifier: 00699753023222
• UDI-Public: (01)00699753023222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 705036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1