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

Model Number A22002A

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device a22002a telescope, 30°, 4 mm was found to have broken lens and cracks on the body.The issue occurred during reprocessing.There was no patient involvement on this report.No user impact or harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr), please see updated sections: g4, g7, h2, h3, h6 and h10.Device return initial investigation found that there was no moisture penetration.A cracked eyepiece funnel as well as particles of broken lenses in the optical system were found which compromised the image.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that the device a22002a telescope, 30°, 4 mm was found to have broken lens and cracks on the body.The issue occurred during reprocessing.The reported issues can most likely be attributed to improper handling by the customer.The damage at the optical system and the eyepiece funnel was most likely caused by undue force (e.G.Impact, accidental dropping).Olympus will continue to monitor the field performance of this device.

• 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: 10282754
• MDR Text Key: 199320960
• Report Number: 9610773-2020-00156
• 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
• Report Date: 08/27/2020

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: 06/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1