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

Model Number 0502-444-030

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

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

Event Date 04/23/2021

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.

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 [blurry] was confirmed.According to henke: scope evaluated as a level 3.Tip and fiber damage, cracked and scratches on distal lens negative.Probably root cause for this failure is: customer use and handling.The failure mode will be monitored for future reoccurrence.The manufacture date is not known.

Event Description

It was reported that there was a blurry image.

• Brand Name: PRECISION IE 4K EYEPIECE 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
• MDR Report Key: 11849895
• MDR Text Key: 255338689
• Report Number: 0002936485-2021-00266
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327405958
• UDI-Public: 07613327405958
• Combination Product (y/n): N
• PMA/PMN Number: K183470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502-444-030
• Device Catalogue Number: 0502444030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1