MAUDE Adverse Event Report: AESCULAP, INC. STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number US906

Device Problem Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated that indicator on the orange locks would not turn to a darker color.No patient injury.No delay in surgery.No additional intervention.

Manufacturer Narrative

D10 - device available for evaluation.Crosstex (sps) recently received a complaint stating that us906 indicator dots were not transitioning to a darker color post sterilization.Suspect product was returned to crosstex for further testing during the investigation of the reported failure mode.The lot numbers provided, 580031-01 and 582691-01, are not recognized as issued by crosstex.Since the lot numbers are reassigned outside of crosstex, we are unable to perform a batch record review.Returned product was subjected to a standard steam sterilization cycle at 270 degrees for four (4) minutes.Two (2) surgical containers consisting of thirty (30) orange locks each were used in an attempt to replicate the results reported for this failure mode.Upon review, it has been determined that all dots tested for both respective lots have transitioned as intended.Since the results could not be replicated, the complaint cannot be confirmed.This issue has been logged and will be monitored for recurrence.Should you experience additional complaints in relation to this failure mode, or should a lot number become available, this complaint will be re-evaluated.Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.

Manufacturer Narrative

Manufacturing evaluation: below outlines the manufacturing process as well as the controls that are in place.All work is dictated by applicable work instructions and inspection forms.All operators are trained to the associated product manufacturing procedures.All operations, including storage, are performed in a temperature and humidity-controlled environment.Indicator ink is applied to the substrate material using a flexographic press, and then dried.A 3/8" die is used to cut the dots.Production samples are subjected to a temperature of 270 degrees fahrenheit for 4 minutes, and then visually inspected by operators for material defects.Slitters cut the material to the appropriate size as determined by the applicable work instruction.Qa performs approval testing and a final check on the material.Us 906 and us 907 rolls are secured in bags and placed in final boxes, according to the associated work instructions.The finished boxes are labelled with the appropriate case label.Product is not released for shipment until qa performs the final release inspection.When a complaint is received and the product lot has been provided, a device history record (dhr) and retain review are performed.The review involves looking for any anomalies during production that might explain the failure.The retain review consists of looking at processed and unprocessed samples.Processed retains are reviewed for color reversion or an incomplete transition during acceptance testing.Unprocessed retains are exposed to a temperature of 270 degrees fahrenheit for 4 minutes.Any discrepancies are noted for the complaint report.To date, the reported ink failures have not been replicated without deviating from the product labeling or instructions for use.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilant.After usage the indicators should not be retained as a permanent record of exposure but rather a photo of the indicator should be utilized due to the indicators' sensitivity to light.The following guidelines should be followed to prevent this failure mode from occurring; avoid prolonged exposure to direct sunlight or uv lighting.Avoid storage at or near any hydrogen peroxide sterilizer.Avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley, pa
• MDR Report Key: 10007689
• MDR Text Key: 189637552
• Report Number: 2916714-2020-00124
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 580031-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1