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 Distortion (3000)

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

Event Date 08/17/2022

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: it was reported by sales rep chase eubanks cmount scope laced it on could not see anything on screen bad overall picture ref rma (b)(4) salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could damaged inner lenses.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was blurry image during procedure.

• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15330057
• MDR Text Key: 300912447
• Report Number: 0002936485-2022-00498
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327416497
• UDI-Public: 07613327416497
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 0502-404-030
• Device Catalogue Number: 0502404030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 10/31/2022
• 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