MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C

Model Number 0502704030

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

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

Event Date 09/23/2021

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 blurry image.

Manufacturer Narrative

The device manufacturer date is not known.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 "image not clear" was confirmed.According to henke: scope evaluated as a level 3.Distal tip/fiber damage, bent needle, dents in needle, damaged sidearm lens, broken lenses, chipped/scratched negative, distal moisture, scratches on needle, residue on external optics and paint missing in engraving.Probably root cause for this failure is: the complaint for ¿image not clear during use¿ has been confirmed and damage is due to customer use and handling.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was blurry image.

• Brand Name: HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C
• 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: 12677875
• MDR Text Key: 280147225
• Report Number: 0002936485-2021-00555
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327062755
• UDI-Public: 07613327062755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093677
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502704030
• Device Catalogue Number: 0502704030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2021
• 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