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

Model Number MAJ-891

Device Problem Device Reprocessing Problem (1091)

Patient Problems Fever (1858); Pain (1994); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reports over the last 1-2 months, a cluster of five patients have been infected with urinary tract infections after endoscopy using one of two cystoscopes with maj-891 and were processed in an oer-s.Bacteria detected in the maj-891 could have led to symptoms in the infected patients.Maj-891 was used in combination with the scope.More than a year ago, there was something like green algae growing on the water filter.In view of this, the facility is concerned about infection caused by oer-s.At that time, the facility staff did not find any abnormalities after the response, so the process was completed without any problems, and there was no problem with the frequency of filter replacement at the facility noted.Microbiological investigation of the reported reprocessor indicates the oer-s is not the source of infection in the reported patients.The five patients developed symptoms approximately ten days after the endoscopy.The patients exhibited fever, chills, pain on urination and frequent urination.Patients were re-examined and prescribed antibiotics at the time of endoscopy.The patients recovered after temporary hospitalization for fever and reported as 'good.' the physician pointed out the possibility of olympus equipment due to the large number of patients who returned to see the doctor after the endoscopy.This event includes the following reports: case with patient identifier (b)(6) reports patient 1 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 2 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 3 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 4 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports patient 5 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports second scope processed in the oer-s (cyf-va2) (potential for cross contamination).Case with patient identifier (b)(6) reports patient infection 1 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 2 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 3 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 4 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 5 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports patient 1 of 5 (maj-891).An additional four reports are being submitted: patient identifier (b)(6) reports patient 2 of 5 (maj-891).Patient identifier (b)(6) reports patient 3 of 5 (maj-891).Patient identifier (b)(6) reports patient 4 of 5 (maj-891).Patient identifier (b)(6) reports patient 5 of 5 (maj-891).This report is for patient identifier (b)(6) reports patient 3 of 5 (maj-891).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus and the device evaluation is captured and has been reported under patient identifier # (b)(6) (related record).Per the device evaluation, a white stain (silicic acid) was observed to be adhered to the screw section where the tightening knob of the forceps/irrigation plug is assembled.The device history record for the subject device (maj-891) was unable to be reviewed, since the serial/lot 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, a root cause of the reported events could not be determined.Although the user reported that escherichia coli and klebsiella pneumoniae were detected from the forceps/irrigation plug that was used in combination with the (cyf-vha) device, and a white stain was observed on the forceps/irrigation plug; a relationship between the subject device and these events could not be identified.However, it is likely that the reprocessing of the device was insufficient, contributing to the event.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 a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Information added to d8.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15700776
• MDR Text Key: 302765709
• Report Number: 9610595-2022-03507
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNK SERIAL: CYF-VHA, OER-S.
• Patient Outcome(s): Other