COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR A37026A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR A37026A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[182455756] The service center was informed that a patient contracted a pseudomonas infection after undergoing an unspecified procedure with the cystoscope. The user facility reported that there was blood in the patient? S urine. The patient? S course of treatment is unknown. As part of our investigation , the service center followed up with the customer to obtain additional information regarding the reported event and was informed that the source of the infection has not been determined as an investigation is ongoing. In addition, an endoscopy support specialist (ess) was dispatched on (b)(6) 2020, to observe the user facility? S reprocessing methods and provide an in-service. The ess reported that there were no reprocessing deviations noted with the facility? S reprocessing practices. However, an in-service was provided that included reprocessing training, brushing, flushing and sterilization. The scope was returned to the service center and is pending physical evaluation and microbial testing. The scope will be sent to an independent laboratory for microbial testing. This is 2 of 2 reports
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2020-00355
MDR Report Key9801453
Date Received2020-03-06
Date of Report2020-03-06
Date of Event2020-01-25
Date Facility Aware2020-02-12
Report Date2020-02-13
Date Reported to Mfgr2020-02-13
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR
Generic NameCOMPACT CYSTOSCOPE
Product CodeGCP
Date Received2020-03-06
Returned To Mfg2020-02-10
Model NumberA37026A
Catalog NumberA37026A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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