MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 165MM, SPEED-LOCK

Model Number 0502-414-070

Device Problems Crack (1135); Insufficient Information (3190)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.The patient was under anesthesia, but no incision was made.

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 the procedure was cancelled.The patient was under anesthesia, but no incision was made.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.According to henke: scope evaluated as a level 3.Distal tip and fiber damaged, broken lenses in system and cracked and scratches on distal lens negative.Probably root cause for this failure is: the complaint for ¿lens cracked¿ has been confirmed and is due to customer use and handling.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 165MM, 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: 14699782
• MDR Text Key: 294385520
• Report Number: 0002936485-2022-00326
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327416435
• UDI-Public: 07613327416435
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502-414-070
• Device Catalogue Number: 0502414070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• 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