MAUDE Adverse Event Report: AESCULAP AG JK442; BOTTOM FOR 1/1 CONTAINER HEIGHT:135MM

Model Number JK442

Device Problem Missing Value Reason (3192)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

Customer states that high infection rates have occurred at this hospital and they are attributing some of the cause on aesculap containers.Sales representative (s/r) and regional sales manager (rsm) met with the customer and reported: "customer had a cluster of infection issues.They obtained the halyard article and decided to start doing a cross section of swabbing/culturing their sets.They tested 16 sets (in aesculap containers) and determined 8 of the sets contained traces of staphus and microcaucus.They tested both the instrument set as well as the container.Sales representative asked the customer what type of testing they had conducted and they said "sterility" testing.They did admit to having a problem with infection and sterility of sets but also said they could not determine if it was the result of a malfunctioning aesculap container.They did however remove all aesculap containers at the end of february as a precaution." when asked if they had tagged and kept the containers that were associated with the contaminated trays they had not.Device listed in this report is representative; item numbers of affected containers/lids was not provided from the end user.

Manufacturer Narrative

No product is at hand.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient reprocessing process.Due to the lack of information, we cannot determine a final root cause of the issue.Based on the quality standards we exclude a material or manufacturing related error.It is conceivable that an insufficient reprocessing processing caused the infection rates.No capa is necessary.

• Brand Name: JK442
• Type of Device: BOTTOM FOR 1/1 CONTAINER HEIGHT:135MM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5600714
• MDR Text Key: 43466739
• Report Number: 2916714-2016-00333
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JK442
• Device Catalogue Number: JK442
• Distributor Facility Aware Date: 03/24/2016
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other