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

Model Number BF-1T150

Device Problems Device Reprocessing Problem (1091); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and the allegation was confirmed.The image is foggy due to damage to the ccd unit, the connecting tube has coating peeling 1mmsq or more, and the light guide lens is dirty with unknown material.Additional device evaluation findings were as follows: distal end has a burn, due to pinching on bending section cover, water tightness is lost, due to damage on ccd unit, the specified resolving power is not obtained and a foggy image occurs, objective lens has discoloration, adhesive on bending section cover is detached, bending section cover has discoloration, connecting tube has a scratch, due to wear of angle wire, bending angle in up/down direction does not meet the standard value, grip has a dent, universal cord has a scratch, control unit has a scratch, due to slipping-out of light guide bundle, illumination is poor, and the up/down angulation lever plate is dirty.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

An olympus field service engineer reported that the bronchovideoscope had a blurred image and distal end had scratches.The issue was observed during routine maintenance.No patient or procedure or harm was associated with this event.The device was returned for evaluation where olympus found the connecting tube had coating peeling 1mmsq or more and the light guide lens is dirty with unknown material.This medical device report mdr is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.E2 was inadvertently selected and should remain blank.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the coating on the insertion section peeling off could not be concluded, although it can be presumed that the defect was caused due to physical stress /chemical stress.The root cause of the dirty lens could not be identified, and the material on the lens could not be identified either.The coating on the insertion section event can be detected/prevented by handling the device in accordance with the following instructions for use: "·preparation and inspection_ inspection of the endoscope 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." "·important information ¿ please read before use.Warning: 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." "·reprocessing manual_ general policy.Precautions_warning: this instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions.For information on the durability against each method, please contact olympus.If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician.Do not use if any abnormality is found." the dirty lens event can be detected/prevented by handling the device in accordance with the following instructions for use: "·reprocessing manual_ leakage testing of the endoscope_ perform the leakage test caution: if you identify a leak during leakage testing, remove the endoscope from the water with the leakage tester still attached.Contact olympus regarding instructions for reprocessing a leaking endoscope in preparation for returning the endoscope to olympus for repair." olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16676073
• MDR Text Key: 312793443
• Report Number: 9610595-2023-05557
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170308185
• UDI-Public: 04953170308185
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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
• Device Operator: Health Professional
• Device Model Number: BF-1T150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2009
• 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