MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE; STERILIZATION ACCESSORIES

Model Number JK100

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that at some point between a set being sterilized and then opened in the operating room, the retention plates are falling off of the lid it is attached to.Time of delay is unknown but approximately 15 minutes to be able to get new sets.In some cases could be 2 hours.The discovery that the filter has fallen in does not happen until the nurse opens the set in the room during surgery.So there are opportunities for multiple delays in time because they have to wait to get a new set or if the patient is already in the room they have to flash sterilize sets.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We found visible damages and unknown impurities on all components.Conclusion and root cause: the root cause of the problem is most likely usage related.Rational: we assume that the damage was cause by improper handling.No capa is necessary.

• Brand Name: FILTER RETENTION PLATE
• Type of Device: STERILIZATION ACCESSORIES
• 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: 5730944
• MDR Text Key: 47590066
• Report Number: 2916714-2016-00515
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JK100
• Device Catalogue Number: JK100
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2016
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: 05/18/2016
• Supplement Dates FDA Received: 02/02/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other