MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. WATER FILTER; SINGLE USE ASPIRATION NEEDLE

Model Number MAJ-2318

Device Problem Particulates (1451)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The acecide was discarded and the water filter was sent in for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is obtained.

Event Description

The customer reported to olympus when the concentration was checked on six (6) endoscope reprocessors (model numbers oer-4 and oer-5), the concentration was determined to be a nanogram (ng), which was lower than expected.Additionally, foreign matter was detected on the oer water filter at the water supply hose attachment port.The customer suspects that there may have been an issue with the disinfectant that was used (acecide) or the water filter.According to the customer, the acecide concentration was checked on the second day of its use and the test strip was pure white.According to the customer, the oer-4 was used nine (9) times around this time.Normally, the customer checks the concentration after five (5) days or after 16 times.The customer was checking the concentration in preparation for cleaning the scopes before a colon examination.The customer did not have any issues with the oer-3s onsite, even when checking the concentration on day six (6).It is unknown when the concentration of acecide first became ng and it¿s unknown if any scopes that had been reprocessed around this time had been used on a patient.There were no reports of patient harm associated with this event.Patient identifiers: (b)(6) (oer-4/sn (b)(4)), (b)(6) (oer-4/sn (b)(4)), (b)(6) (oer-4/sn (b)(4)), (b)(6) (maj-2318), (b)(6) (maj-2318), (b)(6) (oer-5/sn (b)(4)), (b)(6) (oer-5/sn (b)(4)), (b)(6) (oer-5/sn (b)(4)), (b)(6) (maj-2317), (b)(6) (maj-2317) and (b)(6) (maj-2317).

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction as it relates to the subject device (water filter) which is a component of the oer endoscope reprocessor.Per the legal manufacturer, the risk of the disinfection concentration level being below specification is associated with the oer endoscope reprocessor.Therefore, the malfunction has been reported to the fda on the respective oer endoscope reprocessor medwatch and this initial report is no longer applicable.

• Brand Name: WATER FILTER
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• 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: 13596633
• MDR Text Key: 296463038
• Report Number: 8010047-2022-03552
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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: MAJ-2318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/27/2022
• 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: ACECIDE; OER-4 SERIAL NUMBER (B)(6).