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  

Manufacturer Narrative

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

Event Description

It was reported to aesculap inc.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.Although requested, additional information has not been made available.The adverse event is filed under aic reference (b)(4); (b)(4).

Manufacturer Narrative

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

Investigation complete.

• 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
• MDR Report Key: 17493935
• MDR Text Key: 320733638
• Report Number: 2916714-2023-00082
• Device Sequence Number: 1
• Product Code: HCI
• UDI-Device Identifier: 04038653327447
• UDI-Public: 4038653327447
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Distributor Facility Aware Date: 07/16/2023
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening