MAUDE Adverse Event Report: AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER; LIDS BASIS

Model Number JK489

Device Problem Contamination (1120)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint:.

Manufacturer Narrative

Investigation: the investigation was carried out visually in cooperation with the q-coordinator of the aesculap technical service department in tuttlingen.Several sings of wear can be found all over the products.The full-size lid is bent, the holding pins and the area around the pins is deformed.According to the q-coordinator of ats tuttlingen, the execution of the repair was not according to the ats service manual.No ats service stamp can be found on any of the provided products, thus we assume a maintenance by a third party.Conclusion and root cause: 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 usage.Rational: due to the amount of damage and the insufficient maintenance of the products, a proper function can no longer be guaranteed.No capa is necessary.

• Brand Name: FULL-SIZE LID W/RETENTION PLATE SILVER
• Type of Device: LIDS BASIS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7652666
• MDR Text Key: 112854936
• Report Number: 9610612-2018-00272
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK489
• Device Catalogue Number: JK489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Distributor Facility Aware Date: 06/12/2018
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other