MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CHOLEDOCHO VIDEOSCOPE; CHOLEDOCO VIDEOSCOPE

Model Number CHF-V

Device Problem Peeled/Delaminated (1454)

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

Event Date 08/14/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, a section of the coating of the insertion section greater than, or equal to, one square millimeter was peeling off due to deterioration.The reported issue (leak) was confirmed during testing.The bending section cover leaked due to being pierced.In addition, the insertion section was wrinkled due to physical stress, switch one was worn, the switch box was worn, and the protector was worn due to chemical stress.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported that, during reprocessing following a choledocholithotomy procedure, water leaked from the bending section cover.The subject device was sent to an olympus service center for evaluation.During inspection and testing, the coating of the insertion section was peeling off.This report is being submitted for the malfunction found during evaluation (peeled coating).There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The information in event description was inadvertently omitted from the initial medwatch report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the insertion section coating peeled off due to physical stress, chemical stress, etc.The root cause of this event was unable to be identified.The event can be detected by following the instructions for use which state: ¿preparation and inspection_ inspection of the endoscope: inspect the external surface of the entire insertion tube for dents, bulges, swelling, peeling or other irregularities.¿ the event can be prevented by following the instructions for use which state: ¿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: general policy: precautions_warning: this instrument may not be durable, or may not have sufficient durability against the respective methods stated in the guidelines of each country for removing or inactivating prions.For information on the durability against each method, please contact olympus.If reprocessing 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 irregularity before use, and use under responsibility of a physician.Do not use if any irregularity is detected.¿ olympus will continue to monitor field performance for this device.

Event Description

The customer reported that the procedure was completed using a similar device.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO VIDEOSCOPE
• 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: 15974311
• MDR Text Key: 308297347
• Report Number: 9610595-2022-05395
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081456
• 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: 01/24/2023

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: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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