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

Model Number JF949

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 or 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 medwatch 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: no products at hand. Conclusion and root cause: the root cause of the problem is most probably usage and design relate. Rational: the residues are not related to these products. According to the investigation report from nelson labs: "the infared scan plot and library search data are included in appendix a. The fourier transform infared spectroscopy scan has been compared against nelson laboratories, created and commercially available libraries and the five highest matches are provided. The commercial libraries have been produced using the same instrument or may not have been produced using the same method of collection as the original scan. " 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: 7660578
• Report Number: 9610612-2018-00312
• 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

• Device Model Number: JF949
• Device Catalogue Number: JF949
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 06/22/2018
• Event Location: No Information
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Other