MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP STR 7MM; CRANIAL IMPLANTS

Model Number FT740T

Device Problem Product Quality Problem (1506)

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

Event Date 08/12/2021

Event Type  Injury  

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 ft740t - yasargil ti perm std-clip str 7mm.According to the complaint description, the clip does not hold.After removing the temporary clip and installing ft740t the doctor could not clamp the clip.The clip holds for up to a minute then opens.He checked installation with a needle and the clip partially opened the vessel.An additional medical intervention was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Updated h6: codes.Investigation results: visual investigation: the product shows no visible deviation.The investigation was carried out visually and microscopically.Here we found slightly visible traces of use.Additionally the product was sent to the production department for further investigation.Based on the analysis report of subject expert: "the clip closes completely.Mouth is covering.The closing force is 161g.This corresponds to 1.57n, thus in tolerance.No deviations visible on the clip." 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 risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(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.Based upon the investigations results a capa is not necessary.

• Brand Name: YASARGIL TI PERM STD-CLIP STR 7MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12424197
• MDR Text Key: 271938544
• Report Number: 9610612-2021-00596
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT740T
• Device Catalogue Number: FT740T
• Device Lot Number: 52673238
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention