MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM; STERILE TECHNOLOGY

Model Number JK441

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.Opened aesculap tray and saw particles that look like aluminum.

Manufacturer Narrative

Investigation: no product is at hand.An analysis is not possible.Conclusion and root cause: no product available and therefore an analysis is not possible but we assume based on the information available the root cause of the this failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rational: according to the quality standard, a material defect or production error can be excluded.There is the possibility that the particles are abrasions and that the abrasions were caused by a screen basket.No capa is necessary.

• Brand Name: BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7249576
• MDR Text Key: 99318386
• Report Number: 9610612-2018-00059
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK441
• Device Catalogue Number: JK441
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/05/2018
• Date Manufacturer Received: 12/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other