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

Model Number JK100

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with jk100 -filter retention plate.According to the complaint description, the reported incident was against catalog item # jk100 for the following, as stated by the submission form: "surgery found shavings of black plastic in their sterile set.It was found on filter on bottom of pan.They believe it's from plastic of retention plate.They don't have the plate to return for investigation.No case delay or patient harm.They ended up not even using this set, and used an alternative.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report, the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures/preventive measures: based upon the investigation results, a clear root cause conclusion cannot be drawn.There is no indication, for a material manufacturing or design related failure.In the event, that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results, a capa is not necessary.

• Brand Name: FILTER RETENTION PLATE
• Type of Device: ACCESSORIES FOR STERILIZATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11417174
• MDR Text Key: 266709286
• Report Number: 9610612-2021-00075
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK100
• Device Catalogue Number: JK100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1