MAUDE Adverse Event Report: AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER; STERILE TECHNOLOGY

Model Number JK489

Device Problems Residue After Decontamination (2325); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It has been reported that fluff (dark in color) was found inside the containers that have been sterilized.Components in use listed as concomitant devices are: jk489 / full-size lid w/retention plate silver.Jk441 / bottom for 1/1 container height:120mm.

Manufacturer Narrative

Investigation: the investigation was carried out visually.The dust in question is not available for investigation, only pictures were provided.The single use paper filter and filter holders are used, but no damage can be found.The container bottoms and lids are also in used condition, several scratches on the surface, but no significant damages can be found.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably user related.Rational: the provided products are all in good condition, thus we exclude a material or manufacturing related error.Furthermore it is very unlikely that such a large amount of dust can get into a properly working container system.It is conceivable that such an amount of impurities can get into a container, if the user has forgotten to install a paper filter before the sterilization process.No capa is necessary.

• Brand Name: FULL-SIZE LID W/RETENTION PLATE SILVER
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6754361
• MDR Text Key: 81415702
• Report Number: 9610612-2017-00389
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK489
• Device Catalogue Number: JK489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/24/2017
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JK441 / BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM; JK489 / FULL-SIZE LID W/RETENTION PLATE SILVER
• Patient Outcome(s): Other