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

Model Number 0502104030

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

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

Event Date 01/19/2021

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

The device was not received for investigation at stryker endoscopy because it was repaired locally in brazil.The technical service report is attached (see communication log), and indicates: upon receipt in our laboratory of item 0502104030, sn (b)(6).With the complaints described in pi (b)(4).We contacted the client to understand the case and search for the causes of the incident and we identified that in the last months this client had problems with many different models of endoscopes.During this contact, the client reported that the cleaning and sterilization center staff has recently undergone a renovation, and that there are internal training failures.We also found that the endoscopes sent for analysis had signs of dirt adhering to their external lenses, showing an inadequate cleaning procedure.In addition, the hospital's clinical engineering department reported that it received complaints from the clinical staff about some endoscopes, these products were analyzed internally by the hospital's responsible engineer and no defects were found, thus, the endoscope was sent for analysis.Make sure that the preliminary assessment performed in the hospital's engineering was correct and the product really is not defective.As an action for these training problems due to the new employees of the cleaning and sterilization center, we will schedule with the client dates and times to provide the hospital staff with adequate training and prevent similar cases from happening again.Probable root cause: ¿ laser welding seal failure ¿ distal/proximal window solder failure ¿ damage to optical train ¿ damage to needle ¿ damage to distal or proximal windows ¿ moisture intrusion ¿ end of life wear-out ¿ environmental disturbance: endoscope colder than dew point ¿ environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only) ¿ use error the device manufacture date is not known.The reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that there was a blurry image.

• Brand Name: HD 4MM X 30A ARTHROSCOPE SPEEDLOCK A/C
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11464137
• MDR Text Key: 241073198
• Report Number: 0002936485-2021-00139
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327062113
• UDI-Public: 07613327062113
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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: 0502104030
• Device Catalogue Number: 0502104030
• Device Lot Number: 1502575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1