MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART UROLOGY TUBE SET; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number LL0006

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

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 foreign material was found in the sterile packaging.There was no patient involvement and no reported adverse consequences.

Event Description

It was reported that foreign material was found in the sterile packaging.There was no patient involvement and no reported adverse consequences.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: human hair was found.Probable root cause: environmental controls.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: FLUIDSMART UROLOGY TUBE SET
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• 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: 17303023
• MDR Text Key: 319253670
• Report Number: 3007495879-2023-00003
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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 Catalogue Number: LL0006
• Device Lot Number: 113919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1