MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, HYSTEROSCOPE, 2.9MM 30DEG; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number	0502729030
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was blurry image during procedure.
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 attached, the reported failure poor visualization was confirmed.According to henke: scope evaluated as a level 3.Bent needle, dent, distal tip and fiber damaged, sidearm glass damaged, broken lenses in system.The complaint for ¿poor visualization¿ has been confirmed and is due to customer use and handling.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was blurry image during procedure.

• Brand Name: PKG, HYSTEROSCOPE, 2.9MM 30DEG
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17790404
• Report Number: 0002936485-2023-00967
• Device Sequence Number: 7491141
• Product Code: HIH
• UDI-Device Identifier: 07613327059786
• UDI-Public: 07613327059786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 0502729030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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