MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD VELOCITY¿ READER; STERILIZATION PROCESS INDICATOR

Model Number 43220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 05/16/2022

Event Type  Injury  

Event Description

A customer reported that a male health care worker (hcw) experienced an eye reaction while working with the sterrad velocity¿ reader on (b)(6) 2022.The event details were unclear; however, the information available indicated that when the hcw was reading the qr code on an ampoule, he noticed a poor connection with the socket and the device.When he was "handling the wire to try to correct the bad contact," he experienced a flash of light in his left eye, alleged to have originated from the barcode scanner area, and he immediately had trouble with seeing due to visual ¿smudges¿ and spots.The hcw reported the symptoms to an occupational physician the following day, and the physician noted a clot in the central region of the left eye.The hcw then experienced progressive visual blurring during the week after the event.On (b)(6) 2022, he saw an ophthalmologist and was diagnosed with macular injury of the left eye.It was reported the ophthalmologist said symptoms potentially were related to ¿laser exposure¿; however, the cause could not be established with certainty.On (b)(6) 2022, the hcw underwent a nitrogen gas injection procedure for the macular injury.Lastly, the hcw is recovering after the procedure and noted he had blurred central vision and was placed on leave from work.The hcw¿s medical history includes astigmatism and crohn¿s disease, and he regularly takes mesalazine and pinaverium bromide for treatment of gastro-intestinal symptoms.The information suggests the eye injury was serious and a surgical procedure was performed.The hcw reported using the sterrad velocity¿ reader; however, there is no report of product malfunction associated with this serious injury.Furthermore, there is no report that reasonably suggests one of asp marketed devices may have caused or contributed to a serious injury.Based on the information available, and out of an abundance of caution, asp has decided to report this event as a serious injury.

Manufacturer Narrative

(b)(6).The device history record (dhr) was reviewed, and no anomalies were observed that would contribute to this event.The involved unit met manufacturer specifications at the time of release.Asp will continue to follow up for additional event information.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

Manufacturer Narrative

The customer provided a photo of the suspect sterrad velocity¿ reader that includes its placement and setup at the facility.Based on the photo provided, it was observed that a second non-asp unit (3m attest auto-reader, model unknown) is next to the sterrad velocity¿ reader, and both units are placed directly on a heat sealer device.Asp will continue to follow-up for the return of the suspect medical device for evaluation.If additional information is provided, a supplemental report will be submitted as applicable.Per the sterrad velocity¿ reader user guide regarding the barcode scanner: ¿it uses two leds for illumination and aiming, making it possible to scan a barcode in a wide variety of lighting conditions.¿ and per the photobiological safety en 62471-2008 certification report for the riotec barcode scanner engine used in the sterrad velocity¿ reader, the model complied with the requirements for ¿exempt group led product,¿ defined as ¿in the exempt group are lamps, which does not pose any photobiological hazard.¿ the information suggests the chance that the barcode scanner led light could cause a serious injury is remote; however, out of an abundance of caution, asp will continue to deem this event as reportable.In addition, a separate issue was noted based on the review of the unit's placement, and the customer was advised to relocate the unit as per the sterrad velocity¿ reader user guide, under "caution! risk of instrument damage or incorrect results: place the reader on a flat, level surface free from vibration.¿ lastly, additional information was received that the customer has stopped using the suspect sterrad velocity¿ reader.Asp complaint ref #: (b)(4).

Manufacturer Narrative

The suspect sterrad velocity¿ reader was returned, and visual analysis was completed with no defects noted.The velocity¿ reader conformed to the heater block functional verification.All wells were verified as functional with conforming responses to insertions of the temperature probe.The velocity¿ reader conformed to the operational testing verification, and no error messages or defects were noted during testing.The returned sterrad velocity¿ reader was verified as functional as per the normal operation specifications.Asp complaint ref (b)(4).

Manufacturer Narrative

Visual analysis - component verification summary: the internal barcode scanner was visually verified by product analysis lab and found to physically match the riotec (ai3200+shd) engine as per specifications.Per the photobiological safety en 62471-2008 certification report for the riotec barcode scanner engine used in the sterrad velocity¿ reader, the model complied with the requirements for ¿exempt group led product,¿ defined as ¿in the exempt group are lamps, which does not pose any photobiological hazard.¿ asp complaint ref #: (b)(4).

Manufacturer Narrative

Correction: the internal barcode scanner was visually verified to match riotec ai3200(shd), confirmed as an led product.Once the investigational analysis is completed, a supplemental report will be submitted.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis, system risk analysis (sra), and functional analysis.¿ trending analysis for the sterrad velocity¿ reader unit was reviewed from the manufacture date to the event date; no similar events were identified, and no significant trend was observed.¿ review of risk documentation shows the risk for exposure to thermal or electrical energy to be "low." supplier investigation by sanmina - summary: barcode scanner serial number (b)(6).Upon receipt, the tech performed a visual inspection of the unit, indicating there was cosmetic damage to side of unit.The tech booted the unit and found no errors.Review of the part specifications and drawings indicated that both part numbers, ai3200(shd) and ai3200+(shd), contain an led light source, not a laser source.Sanmina reached out to the part supplier riotec, who indicated there were no changes to the part during its manufacture, and riotec tested the part during production to ensure it met specification.The dhr was reviewed, and it was found clear with no failures found for the device during its manufacture or processing.It is concluded that the returned product is not defective and thereby meets the manufactured specification requirements for a properly functioning unit.The assignable cause for the reported eye injury could not be verified.There were no functional issues identified for the sterrad velocity¿ reader, and the barcode scanner was verified to contain an led light source.Per the photobiological safety en 62471-2008 certification report for the riotec barcode scanner engine used in the sterrad velocity¿ reader, the model complied with the requirements for ¿exempt group led product,¿ defined as ¿in the exempt group are lamps, which does not pose any photobiological hazard.¿ advanced sterilization products will continue to track and trend this event.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD VELOCITY¿ READER
• Type of Device: STERILIZATION PROCESS INDICATOR
• 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 14989837
• MDR Text Key: 295726652
• Report Number: 2084725-2022-00207
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037048915
• UDI-Public: 10705037048915
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K170039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 43220
• Device Catalogue Number: 43220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 12/14/2022; 01/17/2023; 04/06/2023; 05/08/2023
• Supplement Dates FDA Received: 08/16/2022; 01/04/2023; 02/02/2023; 05/01/2023; 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2018
• 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): Required Intervention