MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Fever (1858); Pain (1994); Urinary Tract Infection (2120)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports a total of nine patients who underwent a cystourethroscopy with same cysto-nephro videoscope and a forceps/irrigation plug over the course of 25 days presented with fever and pain the next day.After visiting the hospital, antibiotics were prescribed.All of the patients who developed the disease have no sequelae at this time and have not been hospitalized.Urinary tract infection is suspected because all patients developed symptoms after cystourethroscopy using the same scope.Further details as follows: patients who underwent endoscopy continued to come back to the hospital due to the occurrence of symptoms that seemed to be urinary tract infections.Further details of the infections are unknown (aside from fever and pain i the urinary tract.Patient information (initials, gender, age, weight, medical history, constitution, etc.All 9 patients are male.No other information was disclosed.All patients were treated with antibiotics.(intravenous) infusion antibiotics were administered to those with severe symptoms.Patient outcomes: currently, no patients have become severe enough to require hospitalization.The facility believes that olympus products are the cause.The facility speculates the physiological saline solution, or the washing machine could be the cause.There are no current plans to conduct blood tests on other patients undergoing procedures with this same device during this time period.Case with patient identifier (b)(6) reports the scope used in patient/procedure 1 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 2 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 3 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 4 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 5 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 6 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 7 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 8 of 9.Case with patient identifier (b)(6) reports the scope used in patient/procedure 9 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 1 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 2 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 3 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 4 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 5 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 6 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 7 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 8 of 9.Case with patient identifier (b)(6) reports the maj-891 used for procedure 9 of 9.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Please note ¿ the device reported in this complaint was not returned.However, a device (same model number) was returned, and an evaluation completed and documented under patient identifier (b)(6).Therefore, the following device evaluation has been provided based on the results of the related record.The device was returned to olympus for inspection, and the following was observed: there was deterioration of glue which was used at the cock section of the tightening knob and the body causing a gap.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event could not be identified.A relationship between the subject device and the reported patient infection could not be determined.Detailed information regarding the patient infection was unable to be obtained.Also, the user¿s reprocessing steps are unknown.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿if the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms and organic material that could reduce the efficacy of disinfection or sterilization.¿ this supplemental report includes corrections to g2 and h6 from initial medwatch.Also, additional codes added to h6.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information regarding the event was received: disinfection is performed not only after use of the device, but also before use of the device by glutaral preparation.In addition, the subject device is disassembled, then cleaned and disinfected in accordance with the instruction manual.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the customer that was not previously reported.As a result of this new information received, a legal manufacturer re-investigation was performed.However, since no further details regarding the patient infections could still be obtained, the root cause of the reported event remains unable to be determined.However, the customer reported that the subject device was disassembled, cleaned, and disinfected in accordance with the instruction manual.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to h6 code (health effect - impact code).Code "4644" has been added as it was inadvertently not included on the initial medwatch.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• 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 Key: 15926174
• MDR Text Key: 304956365
• Report Number: 9610595-2022-04974
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/21/2023

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 Number: MAJ-891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/10/2023; 02/28/2023; 04/21/2023
• Supplement Dates FDA Received: 01/19/2023; 04/19/2023; 04/21/2023
• 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 Number: 1
• Treatment: CYF-VHA
• Patient Outcome(s): Other
• Patient Sex: Male