MAUDE Adverse Event Report: AESCULAP AG NEEDLE HOLDER SUPER RIGHTING 5MM/310MM; NEEDLEHOLDERS

Model Number PL414R

Device Problems Loose or Intermittent Connection (1371); Deformation Due to Compressive Stress (2889)

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

Event Date 04/15/2020

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 pl414r needle holder super righting 5mm/310mm.According to the complaint description, the customer reported that the upper jaw was loosen during operation.Customer wants to know whether any parts or pieces were detached from the jaw or not.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

Investigation results: as of the date of this report the complaint product was not provided for investigation.Based on the pictures provided, an analysis of the fracture pattern is not possible.This type of corrosion often affects areas or components that have been subjected to high tensile stress.This can be due to design limitations such as screw connections.Reprocessing of the instrument in a state of high tension (for example, closed jaws during reprocessing) can speed up the defect.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 4(5) probability of occurrence 1(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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: NEEDLE HOLDER SUPER RIGHTING 5MM/310MM
• Type of Device: NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11475126
• MDR Text Key: 243945517
• Report Number: 9610612-2021-00080
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL414R
• Device Catalogue Number: PL414R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1