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

Catalog Number LL0006

Device Problem Shipping Damage or Problem (1570)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that foreign material was found in the sterile packaging while setting up for a procedure.There was no patient involvement and no reported adverse consequences.

Manufacturer Narrative

Alleged failure: on (b)(6) 2022, (b)(6) contacted (b)(4) (thermedx tech service).They claim that one tubing set had foreign material in the tubing.This was found while setting up the unit.There was no harm to the patient and the procedure was completed without delay.Probable root cause/root cause: environmental controls.The reported failure mode will be monitored for future reoccurrence.

• 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: kelsey barla ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15328322
• MDR Text Key: 304920646
• Report Number: 3007495879-2022-00004
• 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
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 113228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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