MAUDE Adverse Event Report: AESCULAP AG TUNNELING INSTRUMENT 600MM; HYDROCEPHALUS MANAGEMENT

Model Number FV004R

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

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.

Event Description

It was reported the tip detached intraoperatively.During a surgical procedure, the tip of the device detached in the subcutaneous part of the body.The surgeon noticed upon removal of the device that the tip was missing.A skin incision was added to remove the broken end.It is unknown if x-rays were taken to determine the location or to confirm all pieces were removed.No patient information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018.Investigation: the investigation was carried out visually and microscopically.A visual inspection was made of the instrument.Here we found no broken off area or a broken off part.We only detected visible damage inform of grooves, scratches and quirks.Batch history review: a review of the device quality and manufacturing history records is not possible because the batch number is unknown.Conclusion and root cause: we cannot determine the described error.Rationale: we cannot determined the described error.There is the possibility that another used instrument was sent for analysis.Investigation lead to the assumption that the grooves, scratches and quirks have been caused by using the instrument.Possibly this has been caused by an improper handling.According to the instructions for use the following warning must be observed: excerpt from ifu: safe operation: warning: insert and withdraw the tunneling instrument carefully.Carefully pull the inner line on the other tip of the tunneling instrument until the catheter has been guided through the tube of the tunneling instrument.No corrective/preventive actions needed.

• Brand Name: TUNNELING INSTRUMENT 600MM
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8613643
• MDR Text Key: 145213296
• Report Number: 9610612-2019-00304
• Device Sequence Number: 1
• Product Code: HAO
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV004R
• Device Catalogue Number: FV004R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention