MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOFIBERSCOPE

Model Number BF-TE2

Device Problems Mechanical Problem (1384); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reported that leakage in scope a-rubber (bending section) was found during maintenance/reprocessing.There was no patient involvement on this issue reported.No user injury was reported.The subject device was returned and evaluation found forceps (biopsy) channel port is shaved.This report is being submitted due to the finding of shaved forceps channel port (mechanical issue /physical stress) identified during device evaluation.

Manufacturer Narrative

Device evaluation found a cut on a-rubber and due to cut watertigntess is lost ( leakage was noted).In addition, as stated in section b5, the device biopsy channel was found shaved, scraped.Additional findings unrelated to the reportable event were noted below: adhesive on a-rubber is detached.Connecting tube has a dent.Due to wear of angle wire, bending angle in up/down direction does not meet the standard value.Channel shaft has a foreign material.Control unit sticky.Scratch noted on ud plate, control unit, angulation lever , eyepiece, universal cord and s- cover.A review of the device history record found the subject device was shipped in accordance with specifications.Repair history review found the subject device has never been repaired.The root cause of the reported phenomenon could not be conclusively specify, however, it was presumed that biopsy port was scraped due to rubbing of coil sheath of cleaning brush.Grounds for presumption are as follows: - since biopsy valve is attached during procedure, forceps is unlikely to rub against biopsy port.-since biopsy valve is detached during reprocessing, coil sheath of cleaning brush may rub.Instruction for use (operation manual_ preparation and inspection_ inspection of the endoscope) states : inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available.

• Brand Name: BRONCHOFIBERSCOPE
• Type of Device: BRONCHOFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17796489
• MDR Text Key: 324015200
• Report Number: 9610595-2023-13846
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-TE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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