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

Model Number FV004R

Device Problem Fracture (1260)

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

Event Date 08/04/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with fv004r - tunneling instrument 600mm.According to the complaint description, the plastic wire was torn.This occurred during an unspecified neurological procedure.The wire on the inner tube of tunneler likely came loose and was damaged, causing a tear near the tip.An additional medical intervention was required.An additional skin incision was made.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: 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 a lot number was not provided, a review of the device history records must remain incomplete.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.If the device is returned in the future, an investigation will again be completed at that time.Based upon the investigation results, a capa is not necessary.

• Brand Name: TUNNELING INSTRUMENT 600MM
• Type of Device: HYDROCEPHALUS MANAGEMENT
• 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: 15243052
• MDR Text Key: 298075907
• Report Number: 9610612-2022-00206
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention