MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30, 4 MM

Model Number A22002A

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the device was returned to olympus for evaluation.The user¿s complaint of no image was confirmed.The device was visually inspected and observed lens damage in the optical system.The lens damage is due to excessive stress and force from wrong handling.There was no patient involvement.No additional information was made available at this time.The instruction manual states ¿inspect the entire surface of the scope for dents, protrusions, or other irregularities.Feel the entire shaft with fingers, checking for irregularities.Do not use if damage is found.¿.

Event Description

The user facility reported to olympus that there were image problems with the device.No images were produced.The customer sent the scope in for evaluation.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

This report is being supplemented to provide additional information.

Event Description

The user facility further reported that the scope was swapped out with another scope and the procedure was completed without incident.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.Correction: further investigation by the manufacturer determined this report was reported in error and there is no potential for an adverse event if the defect were to recur.The investigation is based on the information provided by the customer and the service business center.The product was sold on 02jul2015.The customer stated that there was an image problem (no image).According to the investigation, no moisture penetrated the affected device.However, the outer tube was bent, and optical fibers were broken.The most probable cause for the reported error is a damage at the optical system (for example broken lenses).The identified error patterns were very likely caused by external force (impact, drop, fall).The lens system is very delicate.Damage may occur although the surrounding components are without any fault.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.There is no capa associated with this device with respect to the described issue.The risk to patients, users, and/or third parties associated with all reported malfunctions was evaluated as acceptable.The manufacturer will monitor the occurrence rate in the context of our quality management system.

• Brand Name: TELESCOPE, 30, 4 MM
• Type of Device: TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10169673
• MDR Text Key: 198681095
• Report Number: 9610773-2020-00136
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020855
• UDI-Public: 04042761020855
• Combination Product (y/n): N
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,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: A22002A
• Device Catalogue Number: A22002A
• 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: 06/18/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 07/13/2020
• Supplement Dates FDA Received: 06/25/2020; 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1