MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CHOLEDOCHO FIBERSCOPE

Model Number CHF-P60

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported that the scope was leaking.The issue found during an unspecified procedure.The intended procedure however, was completed with another similar device.No more than 15 minutes delay in the procedure was reported.There was no patient harm or injury reported due to the event.Device return evaluation found the coating of the insertion section of the device was peeled off.This report is being submitted for the coating of the insertion section of the unit was peeled off found during device evaluation.

Manufacturer Narrative

The subject device was received and evaluated.Device inspection and evaluation found leakage on the insertion section and the s-connector (scope connector) unit.Black dots were observed on the image.The customer reported issue of the scope "leaking" was confirmed.Furthermore, the coating of the insertion section was found peeled off.Investigation is ongoing.This report will be supplemented accordingly following completion of investigation.

Manufacturer Narrative

This supplemental report is being submitted to correct the aware date of the initial mdr from february 9, 2022, to february 7, 2022, and to provide additional information based on the legal manufacturer¿s investigation.The legal manufacturer reviewed the device history record and confirmed that the device was shipped in accordance with its specification.The complaint database was reviewed, and there was no similar complaint found from the same user facility and/or with the same device but there was one similar complaint received from a different user facility.The legal manufacturer was unable to specify the root cause of the reported event; however, they reported that the most likely cause of the reported event is due to physical stress, chemical damage, storage environment, and so on.The user can detect the suggested event properly by handling the device in accordance with the following ifu statement: preparation and inspection_ preparation and 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.User can reduce/prevent occurrence of the suggested event by handling the device in accordance with the following ifu.·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 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.·storage, transporting outside the hospital and disposal_ storage warning: the storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.Storing the endoscope in direct sunlight, at high temperatures, in high humidity or exposed to ozone, x-rays and/or ultraviolet rays may damage the endoscope or present an infection control risk.

• Brand Name: OES CHOLEDOCHO FIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13690561
• MDR Text Key: 286770063
• Report Number: 8010047-2022-04048
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K843084
• 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: 05/04/2022

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-P60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2010
• 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: CV-S190