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

Model Number	FF012R
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap inc.That a scalpfix applicator (part # ff012r) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, the cartridges were not ejecting and one of the prongs was found to be broken.No patient complications were reported as a result of the event.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the device is in a used condition.Four of the eight teeth of the feed mechanism are missing.Vigilance investigator carried out the pictorial documentation visually and microscopically.Four of the eight teeth of the feed mechanism are missing, fragments have not been provided.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the points of rupture.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1(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: SCALPFIX APPLICATOR
• Common Device Name: SCALP CLIP SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11457001
• Report Number: 9610612-2021-00164
• Device Sequence Number: 19713792
• Product Code: GDO
• UDI-Device Identifier: 04038653222841
• UDI-Public: 4038653222841
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FF012R
• Device Catalogue Number: FF012R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown