MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS; TECHNICAL SERVICE AE 01

Model Number AESCULAP010

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

This report is submitted in reference to information received via medsun report 4100070000-2023-8070.It was reported that there was an issue with the product aesculap010 - unknown aesculap aicon containers.According to the complaint description, "we have discovered that the instructions for use (ifu) for the aesculap aicon containers says the containers are validated for a limited number and type of cannulated instruments.Under section 9, labeled "indications for use", the ifu provides validated lumen configurations.The relevant configuration from the provided table reads "4 stainless steel lumens with > 1mm id < 500mm l".This section appears to indicate that there are no circumstances under which more than four stainless steel lumens can be sterilized in the same container.There is a parallel problem with the aesculap sterilcontainer system ifu.Section 14, "indications for use" provides a table labeled "max no.Of lumens/lumen configuration" which, in the relevant section, reads "1 lumen with = 3mm i.D.X = 400mm l and a second lumen = 3.8mm i.D.X = 370mm l".This would appear to restrict the number of lumens in this system to two, and to further restrict the diameter of acceptable lumens.Contact was made to aesculap representative, for clarification.The representative was confident that the validations reflected in these ifus represent merely the minimum that aesculap had to demonstrate for fda clearance.Documentation was requested that the systems are validated beyond these restrictions, but none have been produced." there was no described patient harm and the event occurred preoperatively.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: h3 - no product for evaluation.H6 - codes updated.Investigation results: the case has been evaluated and documented within an internal risk assessment.No sample was received for investigation.Legal manufacturer confirmed that the instructions for use (ifu) contents were according to requirements.Risk evaluation showed that there is no potential increased risk for patient, user or third parties.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Preventive measures: based upon the investigation results, a capa is not required.

• Brand Name: AESCULAP SURGICAL INSTRUMENTS
• Type of Device: TECHNICAL SERVICE AE 01
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17644800
• MDR Text Key: 322210423
• Report Number: 9610612-2023-00203
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AESCULAP010
• Device Catalogue Number: AESCULAP010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1