• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG Back to Search Results
Model Number MAJ-891
Device Problem Microbial Contamination of Device (2303)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Type  Death  
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 patients adverse events (death and infection). 16 reports are regarding the results for positive of the microbiological testing of the subject device. This is 1 of 28 reports.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
Type of DeviceFORCEPS/ 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 Key10446531
MDR Text Key204160269
Report Number8010047-2020-05781
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K912120
Number of Events Reported1
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 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAJ-891
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
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: 08/24/2020 Patient Sequence Number: 1
-
-