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

Catalog Number 0502000000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Mfg date: the manufacture date is not known at this time.However, should it become available it will be provided in future reports.Gtin: (b)(4).

Event Description

It was reported that the fluidsafe management system is not showing proper defecit levels.The procedure was completed successfully with no medical intervention, surgical delay, or adverse consequences.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: inaccurate reading of fluid.Probable root cause: system design (tolerance stack up issue).Manufacturing / assembly error.Use error.Damage during shipping (inadequate packaging).Damage during shipping (abuse during transit).Damage during cleaning.(b)(4).

Event Description

It was reported that the fluidsafe management system is not showing proper deficit levels.The procedure was completed successfully with no medical intervention, surgical delay, or adverse consequences.

• Brand Name: FLUID SAFE FLUID MANAGEMENT SYSTEM, KIT
• 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: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7011788
• MDR Text Key: 92548961
• Report Number: 0002936485-2017-01071
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022449
• 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: 03/23/2018

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: Other
• Device Catalogue Number: 0502000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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