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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AUXILIARY WATER TUBE

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AIZU OLYMPUS CO., LTD. AUXILIARY WATER TUBE Back to Search Results
Model Number MAJ-855
Device Problems Device Reprocessing Problem (1091); Problem with Removal of Enzymatic Cleaner (1213); Failure to Clean Adequately (4048)
Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2023
Event Type  Injury  
Manufacturer Narrative
The device was not returned to olympus for evaluation.A clinical assessment was conducted on this case and it was found that this event did not meet the requirements of a serious injury (si) due to no health hazards being reported and no additional procedures/intervention being planned or needed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported to olympus, the auxiliary water tube was mistakenly used in combination with a flushing pump in an undisinfected and unsterilized state at the facility in an endoscopy case.It was reported that the facility had two water tubes, one was used for inspection and the other was used for reprocessing.The facility mistakenly used the water tube for reprocessing during a case and as a result, the patient may have ingested endofresh which remained in the water tube pipeline.There were no reports of patient harm.
 
Manufacturer Narrative
This supplemental report is being submitted to provide corrected and additional information based on further review.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information obtained through follow-up (b)(4).The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the suggested event occurred since the user mistakenly was aware of the maj-855 for reprocessing as the maj-855 for a procedure.However, the root cause of the suggested event could not be specified.The event can be prevented by following the instructions for use which state: ¿chapter 9 reprocessing¿ describes the following warning."failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each examination this instrument must undergo thorough manual cleaning followed by high-level disinfection or sterilization." olympus will continue to monitor field performance for this device.
 
Event Description
The customer confirmed the procedure was a diagnostic upper gastrointestinal routine examination.No delay in the procedure in which the subject device was used and the intended procedure was completed.It was realized at the end of the procedure that a non-sterile/disinfected pipeline was used.The patient has no past medical history.The device was inspected prior to use.No hospitalization due to outpatient.No hospitalizations due to events.The patient's current condition is no problem and no problem with exposure of the detergent.No medical intervention (i.E.Treatment outside the scope of the procedure) required as a result of the exposure to the detergent.The patient cannot confirm the material and the customer has the safety data sheet.
 
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Brand Name
AUXILIARY WATER TUBE
Type of Device
AUXILIARY WATER TUBE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key17733319
MDR Text Key323256119
Report Number9610595-2023-13227
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170071508
UDI-Public04953170071508
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K954451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAJ-855
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/12/2023
Supplement Dates Manufacturer Received09/14/2023
09/25/2023
Supplement Dates FDA Received09/18/2023
10/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
GIF-H290Z (B)(6).; OFP-2.
Patient Outcome(s) Other;
Patient Age74 YR
Patient SexMale
Patient Weight62 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
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