MAUDE Adverse Event Report: AESCULAP AG XS APPL.FCPS.STD.TI.90/230MM; CRANIAL IMPLANTS

Model Number FT495T

Device Problem Failure to Fire (2610)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported to aesculap ag that a xs appl.Fcps.Std.Ti.90/230mm (material # ft495t) was used during a procedure performed on (b)(6) 2023.According to the complainant, during an emergency clipping of ruptured aneurysm surgery, the locking aneurysm clip appliers would not release to close the temporary clips.The patient lost a tremendous amount of blood because the temporary clips would neither close or release.The complaint device has been returned to the manufacturer for evaluation.This was a life threatening situation.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: b5 - description updated.D4 - batch and serial number.D9 - product return.H3 - evaluation.H4 - manufacture date.Investigation results: investigation has been carried out in cooperation with the production plant.The forceps has been tested against the test plan valid at the time of production.All dimensions are true to gauge, functional tests, especially the release function, were carried out successfully.Residues can be found all over the surface of the instrument.Device history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch conclusion and preventive measures: based upon the above-mentioned investigation results a definitive root cause could not be established.The forceps is according to specifications valid at the time of production.No failure detected and therefore the sub-items of "conclusion of statistical analysis" cannot be applied.Based upon the investigation results, a capa is not necessary.

Event Description

Update: there was a 5 minute delay in surgery.An additional instrument set was opened and a backup non-locking applier used instead.

• Brand Name: XS APPL.FCPS.STD.TI.90/230MM
• Type of Device: CRANIAL IMPLANTS
• 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: 17493937
• MDR Text Key: 320801765
• Report Number: 9610612-2023-00187
• Device Sequence Number: 1
• Product Code: HCI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT495T
• Device Catalogue Number: FT495T
• Device Lot Number: 52315294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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
• Patient Outcome(s): Life Threatening