MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number BF-1TH190

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The reported phenomenon was confirmed.A physical inspection of the device was performed and it was found that the bending section cover glue was cracked and had been taped.It was also observed that there were excessive frayed wires on the device.Due to the condition of the bending section a leak test could not be performed.This type of damage is most likely due to mishandling or improper storage.The scope was refurbished and returned to the user facility.The instruction manual warns users "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 following regulations, guidelines, etc.Required of you.An endoscope with an observed irregularity should not be used.".

Event Description

Olympus was informed that during a navigational bronchoscopy procedure, the black coating (bending section rubber glue) on the device was noted to be missing.It was reported that no device debris fell inside the patient.The procedure was completed with the same device.There was no patient injury reported.Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the scope is manually cleaned; leak tested, and sterilized using a v-pro max on the flexible cycle.This is the facility's only bronchoscope.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5082052
• MDR Text Key: 26006680
• Report Number: 2951238-2015-00432
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Device Catalogue Number: BF-1TH190
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization