MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number P2000

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 09/08/2022

Event Type  Injury  

Event Description

It was reported that a patient's bladder was perforated during the procedure.

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.

Manufacturer Narrative

The device manufacturer date is not known.Alleged failure: bladder perforation the failure identified in the investigation is inconsistent with the alleged failure.No problem found during functional testing.Probable root cause: based on no problem found and clarification from sales rep (issue occurred during difficulty with entering the ureter).Root cause likely user error with third party instrument.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that a patient's bladder was perforated during the procedure.

• Brand Name: FLUIDSMART FLUID MANAGEMENT SYSTEM
• 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: 16206296
• MDR Text Key: 307703541
• Report Number: 3007495879-2023-00001
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091939
• 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: 03/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other