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

Catalog Number P4000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  Injury  

Event Description

It was reported that the procedure was converted to open because the left internal iliac artery was severed.The user facility stated there was no malfunction of the thermedx device and the investigation is still ongoing to determine which device caused the severed artery.

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 the procedure was converted to open because the left internal iliac artery was severed.The user facility stated there was no malfunction of the thermedx device and the investigation is still ongoing to determine which device caused the severed artery.

Manufacturer Narrative

This complaint was originally opened in the thermedx qms, complaint number 21-0026.The investigation was completed by thermedx, who was the legal manufacturer of the device at the time of this event.The investigation details will be transferred to this complaint.Alleged failure: on june 24th 2022, we were made aware of the device being involved in a procedure where the surgeon severed the left internal iliac during the case and had to open the patient up.The patient recovered and an mdr was opened by stryker.The sales rep and staff stat that the artery was likely severed by a scope not the fluidsmart device.They stated the manufacturer has been notified.The sales rep and staff also stated that they are not alleging a malfunction of the fluidsmart (thermedx) device.The sales rep wanted the device returned to the solon site (thermedx) for evaluation and calibration.Probable root cause/root cause: misinterpretation of instructions (inadequate labeling).The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.

• 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: kelsey barla ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14989300
• MDR Text Key: 295723657
• Report Number: 3007495879-2022-00002
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2022
• 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