MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that between august 2019 and july 2020, after the flexible cystoscopy twelve patients were infected with pseudomonas aeruginosa likely to have been acquired from the subject device.All of the pseudomonas aeruginosa isolates from clinical samples matched strains of pseudomonas aeruginosa isolated from the subject device.The four samples were collected from blood, the one was collected from knee joint fluid, and the seven were collected from urine.Also, microbe was not detected from any samples of the cystoscopes.The six of the affected patients required admission for iv antibiotics, the one of these six patients required intensive treatment unit (itu) admission, and another required multiple surgical procedures for the septic arthritis.Also two of the six patients died after isolating pseudomonas aeruginosa, though it was not clear if their deaths were a direct consequence of the infection as they had other co-morbidities.All elective cystoscopy procedures have been suspended until the devices have been replaced and a suitable decontamination/reprocessing procedure is in place.17 pieces of maj-891 (forceps/irrigation plug) were sampled in total.16 have had bacterial growth.Pseudomonas aeruginosa was isolated from 6 of the devices.5 of these matched pseudomonas aeruginosa isolated from clinical samples.The facility suspected the source might be continued pseudomonas bacteria inside the rubber bungs of maj-891 that the facility attached to the olympus' cystoscope to control water flow.The facility stated that maj-891 did not appear to be reprocessed with the reprocessor.Also the facility was concerned about the reprocessing method of the subject device which was provided by olympus.According to the number of patients and microbiological testing of the subject device, omsc is submitting 28 medical device reports.12 reports are regarding the patient¿s adverse events (death and infection).16 reports are regarding the results for positive of the microbiological testing of the subject device.This is 15 of 28 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) submitted 28 reports and two of which were related to patient death (mfr report # 8010047-2020-05781, 8010047-2020-05883).However, omsc obtained the user¿s report to the competent authority in the united kingdom, the medicines and healthcare products regulatory agency (mhra), and came to know that the report states 1 patient died.Olympus uk & ireland (okm) will therefore try to clarify this with the customer.The user facility provided their investigation results of culturing test for nine cystoscopes used with the subject device, maj-891 (forceps/irrigation plug).Pseudomonas aeruginosa were isolated from the sample collected from t-joint and the rubber bung of four pieces of maj-891.No growth occurred from any samples taken from the instrument channel and external surface of the cystoscopes.As part of our investigation, we checked the reprocessing practice of the user, but olympus could not confirm key steps of the reprocessing, as the user facility did not provide completed response to their reprocessing practice.Olympus has attempted to obtain additional information, no response was provided.The cystoscope used with the maj-891 had been reprocessed with a non-olympus automated endoscope reprocessor model rapidaer of medivators, using non-enzymatic detergent and peracetic acid disinfectant.Olympus has requested the user facility return the devices to olmpus for our evaluation, but no response was provided.The exact cause of the reported phenomenon could not be conclusively determined as olmpus could not obtain enough information needed for the evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus has attempted to clarify whether or not this complaint involves patient death, but could not obtain any response from the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.As a result of multiple attempts to clarify the number of deaths involved in the event, olympus was informed by the user facility that one patient death, and which was not due to the infection.The user facility retested the maj-891 forceps/irrigation plugs after both sterilized and not sterilized, and confirmed that microbes remained on the devices if not sterilized.Reportedly, the user will continue to sterilize the devices and test the devices every three months to ensure the reprocessing practice is acceptable and no infection occurs.The exact cause of the reported phenomenon could not be conclusively determined.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the investigations conducted by the legal manufacturer.A review of the complaint database did not show any previous similar cases from the same user facility prior to these recently reported events.However, olympus found one similar case reported by a different user facility, and based on the investigation result, it was determined that the forceps irrigation plug was not disassembled prior to reprocessing.The instruction for use warns user to make sure that the forceps/irrigation plug is disassembled before cleaning, disinfecting or sterilizing.Olympus confirmed that the maj-891 can be sterilized under uk guideline parameter.Olympus was unable to conduct a device history record (dhr) review because no specific lot number was provided by the user facility.The device master record (dmr) review showed no report on impact of the design change.Based on the current information in the complaint record, there is no information of obvious device mishandling.Olympus cannot confirm the possibility of device not meeting specification, as no device was returned for evaluation.To date, the subject device referenced in this report has not been returned to olympus medical systems corporation (omsc) for evaluation.Thus, the exact cause of the reported event could not be conclusively determined.However, based on the inquiry from the user facility, it is possible that the maj-891 was reprocessed without disassembling prior to its reprocessing.However, considering the inquiry from the facility, it is possible that the maj-891 was reprocessed without disassembling of the maj-891 at the facility while the instruction indicate the disassembling.Thus, inappropriate method of reprocess at user facility cannot be ruled out as the factor of reported event.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• 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: 10452974
• MDR Text Key: 223646377
• Report Number: 8010047-2020-05863
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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