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

Model Number 0502704030

Device Problems Poor Quality Image (1408); Nonstandard Device (1420)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

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

Alleged failure: water intrusion confirmed failure: outer tube damaged (bent, dented),damaged distal cover glass probable root cause: poor mate between cannula and endoscope (i.E.Speedlock or j-lock feature).Poor fit between endoscope needle and cannula.Use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was a blurry image.

• Brand Name: HD 4MM X 30A ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10543795
• MDR Text Key: 208102354
• Report Number: 0002936485-2020-00385
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327062755
• UDI-Public: 07613327062755
• Combination Product (y/n): N
• PMA/PMN Number: K093677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 0502704030
• Device Catalogue Number: 0502704030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1