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

Model Number BF-1TQ170

Device Problems Crack (1135); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the bronchovideoscope had leakage from the bending section.The event occurred during reprocessing.There was no reports of health hazard to the patient or user of the device.The subject device was subsequently evaluated, and confirmed by olympus.The inspection detected the coating peeling on connecting tube more than 1mm2.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The device was returned to olympus and evaluated.The customer¿s allegation was confirmed.The insertion tube inspection buckles, and the coating peels-off.Additional findings are as follows: (a.) due to a cut on the bending section cover, or distal sheath, water tightness is lost, (b.) the plastic distal end cover has a scratch, (c.) the adhesive on the bending section cover, or distal sheath has a crack, (d.) due to wear of angle wire, bending angle in up direction does not meet the standard value, (e.) the control unit has a scratch, (f.) the scope cover has a scratch, (g.) the grip has a scratch, (h.) the up down plate has a scratch, (i.) the angulation lever has a scratch, (j.) the switch box has a scratch, (k.) the light guide connector has a scratch, (l.) the video connector has a scratch, (m.) the video connector case has a scratch, (n.) and the protector of the video cable section has a scratch.A definitive root cause for this issue was not established.However, it is probable that the issue resulted from physical or chemical stress.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist 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, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ furthermore, the reprocessing manual indicates the following: ¿¿ store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage.¿ to prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays, ultraviolet rays, or ozone.¿ to prevent damage, do not store the endoscope and/or accessories with chemicals or in a gas-generating area.¿ do not coil the endoscope¿s insertion tube or universal cord with a diameter of less than 12 cm.Such improper storage may damage the endoscope.¿ 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16970347
• MDR Text Key: 316010743
• Report Number: 9610595-2023-07788
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342943
• UDI-Public: 04953170342943
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121959
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• 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