MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UCT140-AL5

Device Problem Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the olympus service center (oci) for evaluation.The evaluation found the adhesive that covers the screw for the distal end cover/body assembly was missing and the screw was exposed.The light guide cover adhesive was also missing and the probe unit was scratched and chipped.Additionally, the bending section cover adhesive had discoloration and a pin hole.The ultrasonic cord was cracking and scratched.The distal end forceps elevator was loose.A review of the asset scope's history shows the asset was last serviced on september 30, 2020 (no issues found/inspection only).The root cause of the reported event cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Upon receipt of a ultrasonic gastro-videoscope (loaner), the user facility reported that after reprocessing the scope and when gently rubbing the "cracks" with gloved fingers, black residue was observed coming off the distal end of the scope.No patient involvement was reported.

Manufacturer Narrative

This report is being supplemented to provided additional information based on the legal manufacturer¿s final investigation.The following sections were updated: g7, h2, h4, h6, and h10.Based on the legal manufacturer¿s investigation, the dhr was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.No similar complaints for this device have been reported by this or any other facility.The root cause could not be identified.The residues are unlikely to be parts or components used in the manufacturing or assembly of this product.There is a possibility that the residues found on this product came from other materials that the device came in contact with during reprocessing or storage, but this can not be proven with the information available.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-08284.The oem updated the content of the investigation.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, the oem determined that the reported black residue that was found at the distal end of the device during reprocessing was likely due to the deterioration caused by long-term use.This seal material is biocompatible, so dropping it into the body will not affect it.However, since it can be detected in advance by inspection in accordance with the instruction manual, please conduct a reliable pre-use inspection.As stated on the ifu and as a preventive measure, the user manual states: chapter 7 cleaning, disinfection, and sterilization procedures - 7.3 pre cleaning - warning if the endoscope is not immediately pre cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Pre clean the endoscope at the bedside in the procedure room immediately after the procedure.The following steps are to be performed when the light source and suction pump are turned on and still connected to the endoscope.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10754624
• MDR Text Key: 214594157
• Report Number: 8010047-2020-08284
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K012080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GF-UCT140-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1