MAUDE Adverse Event Report: AESCULAP AG SCALPFIX APPLICATOR; SCALP CLIP SYSTEMS

Model Number FF012R

Device Problem Mechanical Jam (2983)

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

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 ff012r - scalpfix applicator.According to the complaint description, the reason for failure - trigger not returning to starting position.The clinic applied the instrument lub to assist in the mechanism, but did not improve the situation.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information - block d4 (lot #, udi), h4.Investigation results: visual investigation: visually, the device provided is in a new condition, no deviation could be found.Device has been forwarded to the q-coordinator of the responsible production plant for investigation.According to investigation report of q-coordinator, the root cause of the malfunction was "too much glue on the sleeve".Stock check has been carried.(b)(4).In order to avoid this failure in future, the complaint has been forwarded to r&d department to check the gluing work-step.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.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.Specifically, it is assumed that there is too much glue on the sleeve.Internal measures were started to avoid this failure for the future.The first step we have initiated is, that we has been forwarded the complaint to r&d department to check the gluing work-step.When the results are available further steps will be taken.

• Brand Name: SCALPFIX APPLICATOR
• Type of Device: SCALP CLIP SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11087991
• MDR Text Key: 227798904
• Report Number: 9610612-2020-00939
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: D021041
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF012R
• Device Catalogue Number: FF012R
• Device Lot Number: 52648193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1