MAUDE Adverse Event Report: AESCULAP AG MINOP HANDLE F/FF385R-FF389R; NEUROENDOSCOPY

Model Number FF432R

Device Problems Fracture (1260); Material Integrity Problem (2978)

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

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with ff432r minop handle f/ff385r-ff389r.According to the complaint description, the tip detached from handle and lodged in occipital horn of the right ventricle.This occurred during a ventricular endoscopy when the forceps had remained open and could not be closed.An additional medical intervention was necessary.The procedure was converted to a craniectomy and the broken part was withdrawn.The patient was then under surveillance in intensive care unit.The adverse event is filed under aag reference (b)(4).Involved components: ff438r minop replacement part f/ff388r; lot, unknown.Ff433r minop outer tube for ff385r-ff389r; lot, unknown.Associated medwatch reports: 400551147 (9610612-2022-00100) pe204a minop ang.Endoscope 30deg 180mm 2.7mm.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Upon review of the evaluation results, the complaint was re-assessed and determined to be an involved component (see b5).Investigation: visual investigation: 400551267 the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".We made a visual inspection of the product.We detected that the tip of the instrument ff438r was broken.We could not found any conspicuities on the fracture pattern.Furthermore the post market data are inconspicuous, we have only this case registered.We have no signs for a manufacturing or design related error.Therefore it could be possible that the tip was broken due to an overloading handling.400551146 the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".The product ff432r is without any error.400551268 the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".The product ff433r is without any error.400551147 this product pe204a was not available.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 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.

Event Description

The adverse event is filed under aag reference (b)(4).Involved components: ff432r- minop handle f/ff385r-ff389r - 400551146 pe204a - minop ang endoscope 30deg 180mm 2.7mm - 400551147 ff433r - minop outer tube for ff385r-ff389r - 400551268.

• Brand Name: MINOP HANDLE F/FF385R-FF389R
• Type of Device: NEUROENDOSCOPY
• 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: 14210034
• MDR Text Key: 290087192
• Report Number: 9610612-2022-00099
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF432R
• Device Catalogue Number: FF432R
• Device Lot Number: 62379458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FF432R- MINOP HANDLE F/FF385R-FF389R; FF433R - MINOP OUTER TUBE FOR FF385R-FF389R; FF433R - MINOP OUTER TUBE FOR FF385R-FF389R -; FF438R - MINOP REPLACEMENT PART F/FF388R - LOT UNK; PE204A - MINOP ANG ENDOSCOPE 30DEG 180MM 2.7MM
• Patient Outcome(s): Required Intervention