MAUDE Adverse Event Report: AESCULAP AG MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM; NEUROENDOSCOPY

Model Number FF399R

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Code Available (3191)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 malfunction of the minop device.During pre-incision testing, the surgeon noted that the overflow channel was not receiving outflow.The patient was on the operating room and prepped when it occurred; however, the first incision had not been made.The originally planned surgery was an endoscopic third ventriculostomy.The surgical team worked to try and solve the issue for about an hour, which delayed the start of the surgery.Also, due to the malfunction of the neuro-endoscopy device, the surgeon decided to perform a shunt insertion instead.The outcome of the procedure was not noted; the minop system was never used on the patient.

Manufacturer Narrative

Manufacturing site evaluation: no product or pictures at hand.Up to now, the product is not available for investigation.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.Based on the quality standard, it appears the cause of the failure is not product related.Therefore, it appears the root cause of the error is most likely usage related.Rationale: without the product, an exact cause cannot be determined at this moment.Based on the quality standard, a material or production related error can be excluded.Surgery residues or tissue could also cause a blockage of the channel.If further investigations are required, the product should be provided for examination.

• Brand Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM
• Type of Device: NEUROENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8529719
• MDR Text Key: 142462442
• Report Number: 9610612-2019-00273
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF399R
• Device Catalogue Number: FF399R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/29/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention