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

Model Number GF-UE160-AL5

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is not yet available for this event.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not available.Upon inspection and testing, the bx channel had an internal cut and was observed to have a leak.User¿s complaint of leaking was confirmed.There is a trace of water invasion in the device and some corrosion.The ultrasound probe unit pink rubber had a cut.Additionally, the ultrasound image had some broken elements, the insertion tube had some buckles and scratches, the control knob had a little play.

Event Description

As reported for this event, during set up for an unknown diagnostic procedure, black substance leaked from the distal end of the device.The device was used in the procedure and there were no issues with the leaking of the black substance.There was no issue during the procedure and no harm or adverse impact to the patient or outcome of the procedure.However, when the device was set back up on the tower, the leaking black substance was observed again.There was no bleeding involved in the procedure, so the leaking substance was not determined to be blood.No leaks were noted in the device at the time of reprocessing.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Initial reporter is an endoscopy technician.Customer corrected their initial reported information that the issue was discovered during set up; the issue of leaking was discovered after the procedure.There were no other devices involved in the event, no delay in the procedure and no devices were replaced during the procedure.Procedure was completed with the same device.The device was inspected and there were no abnormalities found and no visible damage to the insertion tube, handle, or the distal end.The scope was processed in a medivator and all attachments were properly attached and secure prior to reprocessing.Concomitant devices used with the device were a light source 15095a182 and processor 1v594a029.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The probable causes for can be as follows: black substance leaking from the distal end: powder applied to the device in the manufacturing process intruded into the device from flaws or holes of the instrument channel and then was mixed with fluids such as liquid detergent used in the reprocessing process, causing black foreign objects to be leaking from the distal end.A load was applied to the part in question due to an external force produced while the product was transported, stored, used or cleaned, resulting in damage.In the process of the perforation, the needle was inserted through the insertion section of the endoscope with the needle extended from the needle sheath or with the insertion section angulated, leading to perforation of the needle from the inside of the instrument channel.The above is determined to be prevented by conforming to the instructions of the ifu for this product, and therefore the failure phenomenon could have been ascribable to the improper handling of the device by the user.Peeling off of the cover of the ultrasound transducer: a load applied to the part in question due to an external force produced while the product was transported, stored, used or cleaned might have caused the failure phenomenon.The above is determined to be prevented by conforming to the instructions of the ifu for this product, and therefore the failure phenomenon could have been ascribable to the improper handling of the device by the user.The instructions for use includes the following statements which can prevent the issues from happening: chapter 4 operation: 4.3 using endo-therapy accessories.Insertion of endo-therapy accessories into the endoscope (p.57).Caution: ¿do not open the tip of the endo-therapy accessory or extend the tip of the endo-therapy accessory from its sheath while the accessory is in the instrument channel.The instrument channel and/or the endo-therapy accessory may become damaged.¿ caution: ¿hold the endo-therapy accessory close to the biopsy valve and insert it straight into the biopsy valve using slow, short strokes.Otherwise, the endo-therapy accessory could bend or break.¿ 4.6 transportation of the endoscope: transporting within the hospital (p.62).Caution ¿do not hit or drop the distal end of the insertion tube when carrying the endoscope by hand.The ultrasonic transducer internal damage can result and/or the ultrasonic image will be abnormal.¿.

• 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: 10877111
• MDR Text Key: 226341288
• Report Number: 8010047-2020-09233
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

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: No Information
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 12/24/2020
• Supplement Dates FDA Received: 12/18/2020; 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1