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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/25/2020

Event Type  Injury  

Manufacturer Narrative

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 event has been reported by the importer on mdr# 2951238-2020-00355.

Event 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.This is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reported that the most probable cause for the reported event is as follows: the legal manufacturer¿s investigation was based solely on the information provided by the customer and the sale business center (sbc).The product was sold on: 15.04.2005.The investigation is solely based on the information and photos provided by the customer and the sbc.The customer reported that there were internal component failures (impairing the view) and that two patients had pseudomonas infections after having been treated with the same telescope.Based on the photos provided, we can confirm the sbc¿s inspection results or evaluate them as plausible.The photos show residue of some media on the outside of the device, which can clearly be traced back to incorrect cleaning and/or reprocessing.This residue does not seem to be actual corrosion but rather older organic media.The same is true for the reported residue in the working channel of the instrument.Furthermore, the sbc reported foreign material in the eyepiece, which impairs the image display (poor image).No photo of this was provided.Neither did the sbc provide a photo of the bend of the entire outer tube at the main body or of the dents in the area of the eyepiece.Finally, the sbc found minor scratches in the area of the eyepiece.However, this minor damage does not affect the functionality of the device and is therefore considered cosmetic damage.Oste will therefore not elaborate further on the reported minor scratches.The scope was sent to a laboratory for microbiological testing.R&d cds & biocompatibility provided the following statement on the result: ¿apparently, no germs were found.It seems that the laboratory looked both specifically for gram negative bacteria (this also includes pseudomonas) and unspecifically for germs which can multiply in the blood.In both cases, nothing was found.However, the laboratory also pointed out that a false negative test result cannot be ruled out due to the time that had passed before the laboratory test.Foreign material in the eyepiece: since the sbc did not report any leakage, this foreign material could be loose parts of broken lenses, caused by the use of excessive force during use or reprocessing.There might be lens breakage, caused by the bending of the outer tube or by subjecting the eyepiece to an external impact.Bent outer tube and dents in the area of the eyepiece: the reported issues can most likely be ascribed to improper handling by the customer, more specifically the use of excessive force.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: COMPACT CYSTOSCOPE, 7, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR
• Type of Device: COMPACT CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9801554
• MDR Text Key: 192161598
• Report Number: 9610773-2020-00081
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761023221
• UDI-Public: 04042761023221
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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
• Device Operator: 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?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other