MAUDE Adverse Event Report: AESCULAP AG MINOP INVENT 30DG TROCAR D8.3MM L150MM; CRANIAL NEUROENDOSCOPY SYSTEMS

Model Number FH620R

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during use of a scope, things were catching and being cut as they passed through the trocar.The procedure was delayed for approximately 20 minutes as the balloon was sheered off resulting in completion of procedure outside the ventricle.There was no patient harm.Reported potential for sharp internal edges being present.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: no product is available and therefore an analysis is not possible.No capa is necessary.

• Brand Name: MINOP INVENT 30DG TROCAR D8.3MM L150MM
• Type of Device: CRANIAL NEUROENDOSCOPY SYSTEMS
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6042041
• MDR Text Key: 57920126
• Report Number: 2916714-2016-00866
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FH620R
• Device Catalogue Number: FH620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/30/2016
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other