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 Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and observed fiber breakage with debris underneath the cover glass on the distal end affecting the image.Minor dents were found on the eye piece funnel and it was missing the inner and outer light guide adapter.The poor image is due to debris.The device was service and returned to the user facility.

Event Description

The user facility reported to olympus that there are blurry or foggy image problems with the device.The image was cloudy.The customer sent the scope in for evaluation.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The investigation is based solely on the information provided by the customer and service business center (sbc).According to the customer, the image of the telescope is cloudy.The sbc confirmed the issue as reported by the customer and traced it back to particles in the optical system.Based on the data presently available, the manufacturer cannot definitively determine the cause.Our investigator assumes that the reported issues can most likely be attributed to the use of excessive force (e.G.Shock or accidental dropping) and/or wear and tear.The risk to patients, users, and/or third parties associated with all reported issues was evaluated as acceptable.The device history review showed a manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.A capa review determined there is no capa associated with this defect.Risk assessment has been deemed acceptable, no further action required at this time.The manufacturer will monitor the occurrence rate in the context of our quality management system.Correction: after further investigation, the manufacturer determined this defect was reported in error and there is not potential for an adverse event if the defect were to recur.

• 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: 10176797
• MDR Text Key: 198325748
• Report Number: 9610773-2020-00138
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1