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

Model Number A22002A

Device Problem Display Difficult to Read (1181)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and found to have a bent outer tube.There were also chips and breakage found on the objective window.There was also a poor image found from the lens due to breakage.The device was serviced and returned to the user facility.

Event Description

The customer reported that the image was blurry.There was no patient involvement reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that since the product for this complaint was not returned to oste, the investigation was based solely on the information provided by the customer and the sales business center.The product was sold on (b)(6) 2011.The most probable cause of these error patterns is damage to the optical system (e.G.Lens breakage).The reported issue can most likely be traced back to undue force caused by shock, impact or accidental dropping.Please note that the lens system is a particularly delicate component of the telescope.There may be interior damage (lens breakage) even though the surrounding mechanical components do not show any damage.The reported issue can most likely be attributed to improper handling by the customer.The optical system was most likely damaged by undue force (e.G.Shock or accidental dropping).A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issue.

• Brand Name: TELESCOPE, 30, 4 MM
• Type of Device: OLYMPUS HYSTERORESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10160455
• MDR Text Key: 196809009
• Report Number: 9610773-2020-00134
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: A22002A
• Device Catalogue Number: A22002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1