MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH¿ TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE; ARTHROSCOPE

Model Number	HW70942
Medical Device Problem Codes	Break (1069); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that there was a cloudy image and poor illumination due to a broken light guide.Additionally, it was observed that the internal lens was damaged.Upon further inspection it was observed that there were scratches on the tip cover glass.Lastly, it was observed that there was peeling of the gold plating on the outer tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Additional fda 510(k)/ pma: k944072 and k950076.
Event or Problem Description
The customer reported to olympus the telescope "trueview ii", 4 mm, 70°, autoclavable lens had cloudiness.The reported issue was discovered during device inspection.There was no patient/user harm or injury reported due to the event.
Additional 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.Based on the results of the investigation, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
• Common Device Name: ARTHROSCOPE
• 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: 16877442
• Report Number: 3003724334-2023-00008
• Device Sequence Number: 5718182
• Product Code: HRX
• UDI-Device Identifier: 04042761010559
• UDI-Public: 04042761010559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: HW70942
• Device Catalogue Number: A70942A
• Device Lot Number: 569063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 06/27/2024
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 08/01/2023; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400, CABLE.
• Patient Sex: Unknown