MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE

Model Number LF-GP

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The customer reported that the device was working correctly, and the reported problem was resolved.The issue was due to user error.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that, during reprocessing, the connecting tube was popping off the tracheal intubation fiberscope (subject device).The connecting tube could not be connected to the channel connector in the reprocessing basin of the oer-pro.There were no reports of patient harm associated with this event.Subsequently, the customer reported that the device is not being returned because the problem was resolved.The issue was due to user error.Related patient identifiers: (b)(6),connecting tube; serial unknown, (b)(6),endoscope reprocessor; serial unknown.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the definitive root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: "enf/lf endoscope reprocessing manual chapter 4 cleaning and disinfection equipment :the endoscope is compatible with some endoscope reprocessors recommended by olympus.Refer to the instruction manual of endoscope reprocessor for details on operation.:use connectors special to each model when cleaning and disinfecting the endoscope with the endoscope reprocessor.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.The applicable connectors for each endoscope model should be listed in the automated endoscope reprocessor instruction manual.If your endoscope model is not listed in this table, please contact the manufacturer of the endoscope reprocessor.Ifu: connecting tube maj-1511 7 preparation and inspection" olympus will continue to monitor field performance for this device.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Type of Device: TRACHEAL INTUBATION FIBERSCOPE
• 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: 16603425
• MDR Text Key: 312291725
• Report Number: 9610595-2023-04943
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170340215
• UDI-Public: 04953170340215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF-GP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MAJ-1511, CONNECTING TUBE, SERIAL UNKNOWN; OER-PRO, ENDOSCOPE REPROCESSOR, SN UNKNOWN