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

Model Number BF-Q180

Device Problems Crack (1135); Fluid/Blood Leak (1250); Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the insertion tube is leaking.The distal tip cover glue is cracked.The insertion tube is peeling badly and the sheath is torn.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during reprocessing of an evis exera ii bronchovideoscope, a hole was found in the distal tip.There was no patient contact/impact related to this occurrence.

Manufacturer Narrative

This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: in ifu (reprocessing manual), influence of the chemical used exerted on the suggested event was described as follows; 1.4 precautions: this instruction manual specifies disinfection agents and endoscope reprocessors for cleaning, high-level disinfection and sterilization which can be used in combination with the endoscope, and those disinfection agents and endoscope reprocessors which cannot be used with the endoscope.For those that are not listed in this manual, contact olympus-designated service centers, olympus branches or sales representatives.In case that inappropriate disinfection agents or endoscope reprocessors are used, deterioration of the endoscope may be accelerated and parts of the endoscope may come off and may have an adverse effect on patients¿ health.When using these disinfection agents and endoscope reprocessor, follow their instruction manual.Olympus does not guarantee effective cleaning, disinfection and sterilization results in endoscope reprocessors.Contact the manufacturers of those disinfection agents and endoscope reprocessor.3.2 inspection of the endoscope: 5.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.Conclusion: the cause is presumed to be chemical stress or physical stress to the insertion section.According to investigation results, multiple cracks of the insertion section¿s resin were discovered.Therefore, it is presumed that strong chemical stress was applied to the insertion section.The cause of chemical stress was assumed to be an impact of chemical agent used.It presumed that while chemical stress was applied to the insertion section, physical stress was additionally applied to the insertion section, and then, it resulted in the suggested event.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11141579
• MDR Text Key: 243494955
• Report Number: 8010047-2021-01133
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1