MAUDE Adverse Event Report: AESCULAP AG MINOP FIXATION & DISSECTING FCP 2/265MM; CRANIAL NEUROENDOSCOPY SYSTEMS

Model Number FF388R

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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 ff388r - minop fixation & dissecting fcp 2/265mm.According to the complaint description, the minop endoscope instruments have been damaged by tssu.The tactile feedback springs along the shaft they think have been bent.This has resulted in a shard of metal being spotted in the patients ventricle which they believe they retrieved using one of our disposable aspiration needle kits.The patient had gone for a ct scan and an "aid" has been raised.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00872 (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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 there is capa is not necessary.Associated medwatch: 9610612-2020-00872 ((b)(4)).

• Brand Name: MINOP FIXATION & DISSECTING FCP 2/265MM
• Type of Device: CRANIAL NEUROENDOSCOPY SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10976748
• MDR Text Key: 220470035
• Report Number: 9610612-2020-00871
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• PMA/PMN Number: K983365
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF388R
• Device Catalogue Number: FF388R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other