MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 0502990030

Device Problems Poor Quality Image (1408); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that there was blurry image during procedure.

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.

Manufacturer Narrative

Alleged failure: (b)(6), onsite, bad image, (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be improper sterilization methods and/or excessive force applied to the scope.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was blurry image during procedure.

• Brand Name: PKG, CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE
• Type of Device: 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: 16542258
• MDR Text Key: 311502937
• Report Number: 0002936485-2023-00218
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327063981
• UDI-Public: 07613327063981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502990030
• Device Catalogue Number: 0502990030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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