MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:90MM; STERILIZATION CONTAINERS

Model Number JK740

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Event Description

It was reported that there was an issue with jk740 -bottom for 3/4 container height: 90 mm.According to the complaint description, the container was "contaminated" with white powdery residue.This malfunction had occured during disinfection.Additional information is not available.The product was not used in surgery.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Event Description

Update: the adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4)(9610612-2022-00248) - jk740.(b)(4) (9610612-2022-00221) - jk740.Involved components: jk789 - 3/4-size lid w/retention plate silver, batch (b)(4).

Manufacturer Narrative

According to our review of reporting evaluation, this event is considered no longer reportable for the following reason: patient harm was updated to "no" per reporter and failure mode risk analysis adjusted to severity 2(5).

Event Description

Update: there was no patient harm.Associated medwatch reports: 400564640 (9610612-2022-00248) - jk740.400565269 (9610612-2022-00221) - jk740.Involved components: jk789 - 3/4-size lid w/retention plate silver, batch 52563153 (400564638).

• Brand Name: BOTTOM FOR 3/4 CONTAINER HEIGHT:90MM
• 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: 15191952
• MDR Text Key: 302246305
• Report Number: 9610612-2022-00248
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K792558
• 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,Followup
• Report Date: 09/07/2022

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: JK740
• Device Catalogue Number: JK740
• Device Lot Number: 52560237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/10/2022; 09/01/2022
• Supplement Dates FDA Received: 08/18/2022; 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: JK789 - 3/4-SIZE LID W/RETENTION PLATE SILVER.; JK789 - 3/4-SIZE LID W/RETENTION PLATE SILVER.