MAUDE Adverse Event Report: AESCULAP AG XS APPL.FCPS.STD.TI.90/230MM; CEREBRO VASCULAR CLIPS

Model Number FT495T

Device Problem Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

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 intraoperative issue with the cerebrovascular aneurysm applier.As the surgeon was clipping the aneurysm, the applier did not release the clip properly.After a couple of attempts, the clip was able to be removed.A different clip applier was used instead to complete the procedure.The surgeon expressed significant concerns about the patient status during the incident.There was no surgical delay.Additional information has been requested.

Manufacturer Narrative

Investigation: the instrument arrived in a clean status without visible damage.We received a complaint about one ft495t.Intra-operative medical intervention was necessary.The investigation was carried out visually and microscopically.We made a visual inspection of the instrument.Here we found a deviation between the batch number of the labeling of the package and the production labeling on the left side of the aesculap sign: labeling of the package (batch number xx ).Production labeling on the left side of the aesculap sign the number 50 stands for the production plant aag tut and the number 04 for the production year 2004.Additionally we detected scratchesand signs of usage.For further analysis we dismantled the instrument here we discovered a different pairing code between the parts.One code is 2726 and the other is 2440.Additionally the instrument was inspected by the quality assurance of the production department.It was noticed that the 3-fold pairing code does not match.This could happen in the central sterilization department of the hospital.On the production side, no faults can be detected.Batch history cause the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause the root cause of the problem is most probably reprocessing / maintenance related.Rationale according to the quality standard a material defect and production error can be excluded.Investigations lead to the assumption that the not matched pairing code was caused by assembling after reprocessing.Therefore the instrument is not true to gauge and this could led to the described error "applier wouldn't release clip".According to the investigation report of the quality assurance of the production department: "specification: the ft495t is manufactured and inspected according to the approved work plan and the current drawing including the valid guardus test plan.In segment 320 the pliers are labeled incl.3 times pairing code.Current state: after dismantling the ft495t pairing pliers, it was noticed that the 3-fold pairing code does not match.I.E.On the outer tube and on the handle the number 2726 is inscribed.On the inner core the number 2440.Thus the probability is very high that the laying tongs are not true to gauge, and thus the function is not guaranteed.The forceps were most likely not assembled with the right soul in the central sterilization department of the hospital." additionally to the statement of director organization instrument manufacturing: "the instrument is not true to gauge!" furthermore there is the possibility that a second instrument with a not matched pairing code is circulated by the customer.Please check.This instrument could also not be true to gauge.

• Brand Name: XS APPL.FCPS.STD.TI.90/230MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8874363
• MDR Text Key: 153714892
• Report Number: 9610612-2019-00531
• Device Sequence Number: 1
• Product Code: HCI
• Combination Product (y/n): N
• PMA/PMN Number: K131500
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT495T
• Device Catalogue Number: FT495T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP; CLIP