MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP STR 9MM; CRANIAL IMPLANTS

Model Number FT750T

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with the product yasargil ti perm std-clip str 9mm.Specifically, it was reported the nurse unfolded an new aneurysm clip and found that aneurysm clip did not fit well and cannot be used.There was no patient harm.Additional information was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

The implant is not available for investigation.Only a photo is available from the customer, therefore a investigation of the product is not possible.Due to the lack of information it is hardly to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.

Manufacturer Narrative

Investigation results: the investigation was carried out visually with the digital-camera "panasonic dmc tz8." we made a visual inspection of the product.Here we found misaligned jaws.For further investigation the product will be decontaminated internally.Should the investigation reveal new evidence, leading to a different conclusion, this report will be adapted.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of the risk assessment revealed that the overall risk level (severity 3(5) probability of occurrence(5) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.If new information are available, we will update this case in a supplemental report accordingly.Based upon the investigations results there is capa is not necessary.

• Brand Name: YASARGIL TI PERM STD-CLIP STR 9MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10245624
• MDR Text Key: 202996595
• Report Number: 9610612-2020-00256
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT750T
• Device Catalogue Number: FT750T
• Device Lot Number: 52479788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1