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

Model Number JK489

Device Problem Residue After Decontamination (2325)

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

Event Date 08/30/2021

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 jk489 - full-size lid w/retention plate silver.According to the complaint description, there was an unknown residue on the lid.Clear glue material was found beside the gasket stuck to lid.There was a delay or 5 mins to retrieve new set.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: b5 - update d9 - no product return.H6 - codes updated.The investigation was completed and the complaint re-assessed.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered no longer reportable for the following reasons: - no serious incident.Investigation results: as of the date of this report the complaint product was not provided for investigation.The investigation was based upon analysis of historical data review.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.(in 2021, 4 deliveries were made to customer.In the past 5 years, only 1 similar complaint had been identified).Likely, a production or design-related cause can be ruled out.Conclusion/preventive measures: in the light of the little information received and due to the circumstance that the complained device was not received it is not possible to determine a root cause for the mentioned failure.There is no indication for a material-, manufacturing- or design related failure.In the event that the complaint product will be received for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not required.

Event Description

Update: there had been no patient involvement.

• Brand Name: FULL-SIZE LID W/RETENTION PLATE SILVER
• Type of Device: STERILIZATION CONTAINERS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12510129
• MDR Text Key: 272708876
• Report Number: 9610612-2021-00624
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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: Health Professional
• Device Model Number: JK489
• Device Catalogue Number: JK489
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1