MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH COMPACT CYSTOSCOPE, 7, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR

Model Number	A37026A
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
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)(4) 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.

• Brand Name: COMPACT CYSTOSCOPE, 7, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: COMPACT CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9801497
• Report Number: 2951238-2020-00356
• Device Sequence Number: 13599710
• Product Code: GCP
• UDI-Device Identifier: 04042761023221
• UDI-Public: 04042761023221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 02/13/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: A37026A
• Device Catalogue Number: A37026A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other