MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM; RIGID ENDOSCOPE TELESCOPE

Model Number A22003A

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6), (added due to character limitation in respective field).

Event Description

It was reported, the telescope was cracked at the scope camera connection.The issue occurred during inspection for use of a therapeutic turis procedure.There were no reports of patient harm although there was a 3 minute delay.The procedure was able to be completed using a similar device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, it is likely that the event occurred due to an effect of an excessive mechanical force caused by an impact or fall.However, the definitive root cause was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 70°, 4 MM
• Type of Device: RIGID ENDOSCOPE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18993800
• MDR Text Key: 338921358
• Report Number: 9610773-2024-00895
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020862
• UDI-Public: 04042761020862
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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: A22003A
• Device Lot Number: 662575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HD CAMERA HEAD