MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM; CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN

Model Number JK342

Device Problems Problem with Sterilization (1596); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.There is an increasing amount of sets being sent back to spd due to residue found inside container after sterilization.The operating room staff is doing a "white glove test" - where they will swipe the bottom of the container after removing the basket.After swiping the bottom of the container the or staff (in some cases) are finding a dark residue on glove.No patient injury.Delay in surgery.All med watch submissions related to this report are: 9610612-2018-00288, 9610612-2018-00289, 9610612-2018-00290, 9610612-2018-00291, 9610612-2018-00292, 9610612-2018-00296, 9610612-2018-00312.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visible inspection of the container bottom.Here we found visible damages.Conclusion and root cause: the root cause of the problem is most probably usage and design related.Rational: we assume that the damages at the filter retention plate jk100 were caused by improper handling.Corrective action: a product safety case will be initiated.

• Brand Name: BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
• Type of Device: CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7660565
• MDR Text Key: 113185360
• Report Number: 9610612-2018-00290
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK342
• Device Catalogue Number: JK342
• Distributor Facility Aware Date: 06/22/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other