MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30, 140MM, SPEED-LOCK

Model Number 0502-404-030

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

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

Event Date 12/30/2020

Event Type  malfunction  

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 Description

It was reported that there was a blurry image.

• Brand Name: PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30, 140MM, SPEED-LOCK
• Type of Device: ARTHROSCOPE
• 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: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 11230471
• MDR Text Key: 229808683
• Report Number: 0002936485-2021-00054
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0502-404-030
• Device Catalogue Number: 0502404030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse