MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER; STERRAD® EQUIPMENT

Catalog Number	10104
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Initial reporter phone number: (b)(6).An asp field service engineer (fse) was dispatched to assess the unit onsite.The fse tightened the screws of the shelf support to resolve the reported issue.The fse completed successful tests and confirmed that the unit met specifications.The system was returned to service.The device history record was reviewed and no issues related to this failure mode were noted.The unit involved met manufacturer specifications at the time of release.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 or Problem Description
It was reported by a hospital in japan to asp japan by means of the complaint process, that after a load was sterilized, a female health care worker (hcw) pulled out the top shelf of a sterrad 100nx sterilizer and it slipped and fell partially out.It was noted she ¿panicked¿ and tried to stop the shelf from falling with her finger and fractured her middle finger on her right hand.It was noted the hcw did not get her fingers stuck in between the shelf rails when she panicked.After checking inside the chamber, it was noted that the upper chamber stop was loose on the right side.Clinical details were provided, which reported the hcw received medical attention, and a bone fracture was diagnosed and confirmed by x-ray.A ¿cast¿ or splint was applied which is considered standard of care.No medication was given.The hcw is expected to make a full recovery by (b)(6) 2025, and it was reported she had already come back to work.This complaint is deemed reportable as a serious injury.The customer reported that a hcw panicked and fractured her finger when trying to stop the shelf from falling.
Additional Manufacturer Narrative
Correction to h6: medical device problem code: updated from material integrity problem (2978) to mechanical problem (180).H3: asp investigation summary: the investigation included a review of the device history record, trending analysis of the issue, and system risk analysis.Trending analysis of the issue for the sterrad®100nx unit was reviewed for the prior six months from the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to mechanical or physical force to be "low." no parts were replaced nor were parts returned, so product evaluation was not performed.The assignable cause of this complaint is likely due to the chamber plastic stop rotating out of position.The asp field service engineer tightened the screw of the upper shelf chamber stop and confirmed the sterrad 100nx was restored to proper function after service.The issue has been resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: cmp-(b)(4).

• Brand Name: STERRAD® 100NX STERILIZER
• Common Device Name: STERRAD® EQUIPMENT
• 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: brent lewis ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 23303621
• Report Number: 2084725-2025-00002
• Device Sequence Number: 21359057
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (Y/N): N
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10104
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female