MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE WASHING PIPE

Model Number PW-205V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Keratitis (1944)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that during an endoscopy using the subject device(spray catheter), the following event occurred.While trying to inject the lugol with the subject device, the device was disconnected due to hyper pressure, and some lugol got into the user's left eye.The device was no longer available.The user suffered a corneal burn and had local treatment.There was no sick leave.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Search was carried out for any complaints made in which the same product lot behaved the same or similarly to the reported event.However, there have been no report.Although the actual device was not sent, it is possible to infer the cause from the investigation results of similar cases in the past, so it is unnecessary to investigate using the same structure of equipment and similar equipment.It was judged.The subject device could not be confirmed, and dhr presented no abnormalities.Therefore, the exact cause of the chemical solution scattering could not be determined.Based on similar complaints in the past, likely factors causing the chemical solution scattering might be the following: *the injection port was not fully connected to the syringe, and the connection was loose.*the stylet was not fully connected to the proximal side.The above device handling has warned in the instruction manual as follows.*when using the instrument, always wear appropriate personal protective equipment.Otherwise, blood, mucus and other potentially infectious material from the patient could pose an infection control risk.Appropriate personal protective equipment may include: eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report #8010047-2021-07273.Olympus concluded that there was no mdr reportable malfunction or adverse event.

• Brand Name: DISPOSABLE WASHING PIPE
• Type of Device: WASHING PIPE
• 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: 11963584
• MDR Text Key: 255088196
• Report Number: 8010047-2021-07273
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PW-205V
• Device Lot Number: 07K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other