MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA BRONCHOVIDEOSCOPE; BRONCHOFIBERVIDEOSCOPE

Model Number	BF-3C160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An endoscopy support specialist (ess) visited the user facility to inspect the referenced scopes, but the gi manager indicated that the scopes were sent out to their third party repair facility for inspection.The ess recommended to send the scopes to the manufacturer for evaluation after the third party facility inspection is completed.A review of the scope's instrument history indicates, the scope was sold on (b)(4) 2007 and was last sent to the manufacturer for repair on may 15, 2015.The customer provided a photograph of the reported issue.Based on the ess and a review of the instrument history information, insufficient/improper maintenance cannot be ruled out as a contributory factor to the reported event.The exact cause of the reported event cannot be confirmed as the investigation is ongoing.As a preventive measure, the instruction manual provides warning that indicates: 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.This instrument is to be repaired by the manufacturer's technicians only.Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.
Event or Problem Description
The manufacturer was informed that during an unspecified procedure, the seal from around the lens of the scope was found inside the patient's airway after intubation.The piece was suctioned out of the endotracheal tube (et) without harm to the patient.The scope was removed and replaced.The procedure was completed using a new scope.In addition, the scope was inspected prior to use and showed no visual signs of damage.

• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8822086
• Report Number: 8010047-2019-02678
• Device Sequence Number: 19603479
• Product Code: EOQ
• UDI-Device Identifier: 04953170063039
• UDI-Public: 04953170063039
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K023984
• 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
• Report Date (Section B): 07/24/2019

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: BF-3C160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1