MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS UNKNOWN STERRAD; STERILIZER, CHEMICAL

Device Problems Fire (1245); Smoking (1585)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted out of an abundance of caution due to allegation of fire for an unknown sterrad unit.It is unclear which specific component was affected, and it is unknown whether the reported issue originated within the system or caused by external factors.Medwatch report mw5115140 was forwarded from the fda noting that the report contained ¿all the information presently available.¿ the suspect medical device in this event could not be identified based on the information provided and noted ¿insufficient information¿ for clinical signs and symptoms.No additional event details were reported.Furthermore, no contact information for the affected facility was provided; therefore, no additional information could be obtained for this reported event.Since the suspect medical device is unknown, no device history record (dhr) could be reviewed, and no information regarding device service record or maintenance history could be verified; therefore, no determination of possible contributing factors could be assigned.If the suspect medical device is made available for evaluation in the future or additional information is provided, the investigation will be conducted as appropriate.The complaint database was reviewed, and no other system-fire malfunctions have been identified.The sterrad systems are designed to meet applicable portions of the (b)(4) electrical safety standards, including flammability rating.Review of risk documentation shows the risk for exposure to toxic or corrosive material and thermal or electrical energy to be "low." this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).

Event Description

It was reported via medwatch form mw5115140 from an unknown facility that ¿sterrad lamp control caught fire and started smoking¿ and ¿filled the area with smoke¿.There were no clinical signs or symptoms reported and no further event details were available.

• Brand Name: UNKNOWN STERRAD
• Type of Device: STERILIZER, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 16651820
• MDR Text Key: 312398333
• Report Number: 2084725-2023-00065
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1