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

Catalog Number P2000

Device Problem Pressure Problem (3012)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

Alleged failure: on (b)(6) 2021 matt wolfe (tech service) received a call from (b)(6) (rep) explaining that sn (b)(4) was presenting an overpressure sensor error alarm.Per 00824 operation manual rev k.An over pressure alarm will present itself when the pressure set point exceeds 10% or 12mm/hg.No one was injured as a result.Probable root cause/root cause: incorrect procedure selection, or insufficient fluid pressure or flow, compromising visibility.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the device displayed an overpressure sensor error alarm.There were no reported adverse consequences as a result.

• 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: 15328325
• MDR Text Key: 305497428
• Report Number: 3007495879-2022-00005
• 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: P2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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