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

Catalog Number 0502000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electrolyte Imbalance (2196)

Event Date 10/31/2017

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that the patient experiencing electrolyte imbalance after the procedure.The procedure was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: fluid safe management case with a high deficit.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be user set up, or out of calibration.(b)(4).

Event Description

It was reported that the patient experiencing electrolyte imbalance after the procedure.The procedure was completed successfully.

• 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: 7065664
• MDR Text Key: 93166856
• Report Number: 0002936485-2017-01149
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0502000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other