MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE; ARTHROSCOPE

Model Number 0450000000

Device Problems Output Problem (3005); Pressure Problem (3012); Failure to Eject (4010)

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

Event Date 12/01/2021

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 potential of overpressure.Please note, it was not able to be confirmed whether this occurred during a procedure.

Event Description

Per additional information received, this did not occur during a procedure.This event description most likely indicates ¿tube set does not disengage¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.Therefore making this event not reportable.

Manufacturer Narrative

Alleged failure: cib allan, endo, please eval, presure was set to 25 but flowing at 65- cartredge is jammed po wcb.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) broken pressure sensor/ malfunction.2) user settings.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Per additional information received, this did not occur during a procedure.This event description most likely indicates ¿tube set does not disengage¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.Therefore making this event not reportable.

• Brand Name: PKG, CROSSFLOW CONSOLE
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13115118
• MDR Text Key: 285329099
• Report Number: 0002936485-2021-00733
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123441
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0450000000
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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