MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number	0502990070
Medical Device Problem Codes	Fogging (1253); Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scope was cloudy.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Additional Manufacturer Narrative
This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record, the reported failure "cloudy " was confirmed.According to henke: this scope was received on (b)(6) 2026, evaluated as a level 2, scratches and knicks at the distal, damage to the distal fibers, particulates in the system, loose prism lens and broken internal optics.No discrepancies found on the dhr.The damages to the product were caused by customer use/handling the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the scope was cloudy.

• Brand Name: PKG, CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 24491378
• Report Number: 0002936485-2026-00134
• Device Sequence Number: 10617253
• Product Code: HIH
• UDI-Device Identifier: 07613327063998
• UDI-Public: 07613327063998
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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 Catalogue Number: 0502990070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown