MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO DISPOSABLE PROBE; SYSTEM, THERMAL REGULATING

Catalog Number DP400CE

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Bowel Perforation (2668)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

The probe was not being used with a meditherm, altrix or any other temperature therapy device but was being used to monitor the patient temperature because the patient had renal failure so they were unable to use a foley probe.The customer did not save the disposable probe or the packaging.Device was disposed.

Event Description

It is reported the customer had a trauma patient in their trauma bay of their emergency department and during the ct they allege that they found that the ¿probe pierced the posterior rectal wall with the tip in pre-sacral adipose tissue with a small amount of free fluid in the posterior pelvis¿.Ct said that this alleged finding was an incidental finding.

Manufacturer Narrative

Added catalog and gtin numbers.Communication with the user facility identified that a dp400ce probe was found to have pierced the posterior rectal wall of a patient after it had been inserted.The patient was alleged to have several traumas when they came into the hospital.It was stated that the probe was not used with a meditherm or altrix unit.The incident was identified during a ct that was performed after the patient had passed away.It was stated that the incident with the probe did not require any additional treatment or medication to be given to the patient.The user facility is not attributing the patients passing to the probe piercing the rectal wall and stated that it was an incidental finding during the ct.A stryker sr clinical nurse consultant will provide training to the account on proper positioning of the probe.

Event Description

It is reported the customer had a trauma patient in their trauma bay of their emergency department and during the ct they allege that they found that the ¿probe pierced the posterior rectal wall with the tip in pre-sacral adipose tissue with a small amount of free fluid in the posterior pelvis¿.Ct said that this alleged finding was an incidental finding.

• Brand Name: DISPOSABLE PROBE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7621109
• MDR Text Key: 111736546
• Report Number: 0001831750-2018-00604
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: DP400CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1