MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.The scope¿s instrument channel was leaking.There was a dent on the insertion tube.Further evaluation found excessive guide fiber breakage, the bending section detached and dried fluid within the connector and control unit.A third party bending section cover was noted on the scope.The cause of the reported event could not be determined at this time.The content of the this complaint will be reviewed by the legal manufacturer for further review.The instruction manual provides warnings to prevent biting of the scope and statements to educate the user about proper maintenance and repair.Please reference the following sections: insertion of the endoscope ¿to prevent the patient from accidentally biting the insertion section during an examination, it is strongly recommended that a mouthpiece be placed in the patient¿s mouth before inserting the endoscope.Maintenance management the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase.In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically.An endoscope with an observed irregularity should not be used, but should be inspected by following section 10.1,¿troubleshooting guide¿ on page 145.If the irregularity is still suspected after inspection, contact olympus.Prohibition of improper repair and modification this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage can result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.¿ in addition, this mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
The service center was informed that the scope was noted to be leaking from both ends and there was bite damage at the tip.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the lm investigation.Please see the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.As a result of the dhr review, there were no abnormality in manufacturing, concession, and variation.The lm reported that the most probable causes for the reported event are as follows: · in this case, the leak occurred at approximately 20 cm of the insertion tube, so it can be confirmed that there was biting.Therefore, it is likely that the external force due to biting applied to the site was injured.Supplement · as a result of qir checks, it has been confirmed that repair of the bending section rubber and bending section adhesive had been performed by non-olympus third party.The legal manufacturer reported that as olympus was unable to assure the device, it should be cautioned not to perform repair by a third party.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10583797
• Report Number: 8010047-2020-06841
• Device Sequence Number: 2822700
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2021

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: BF-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 01/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1