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 Unspecified Infection (1930)

Event Type  Injury  

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 (b)(6) 2019 and (b)(6) 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 6 of 28 reports.

• 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: 10453021
• MDR Text Key: 212973156
• Report Number: 8010047-2020-05885
• 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

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/01/2022

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?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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?: 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 Treatment Data

Date Received: 08/26/2020 Patient Sequence Number: 1