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

Model Number FH620R

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

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 fh620r - minop invent 30dg trocar d8.3mm l150mm.According to the complaint description, the two components do not fit together and therefore cannot be used.Both individual parts seemed to have been in proper condition.There are adhesive residue on optics.There was no described patient harm.The malfunction is filed under aag reference (b)(4) associated medwatch-reports: 9610612-2021-00327 ((b)(4) + fh620r), 9610612-2021-00326 ((b)(4) + pe204a).

Event Description

The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

"investigation results/ visual investigation: the investigation was carried out visually and microscopically.A foreign substance can be found on the shaft of the endoscope.Visually, no deviation can be found at the trocar.The foreign substance at the shaft is probably adhesive, most likely caused by an improper montage of the endoscope.Furthermore, the measures of the endoscope has been checked, but partially found to be not according the specification.Therefore the failure described by the customer could be simulated, a montage of the components was not possible.Batch history review: review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.Specifically, it is assumed that the foreign body, on the shaft of the endoscope is most likely glue.This is not a systematic error.The dimensional deviations are manufacturing errors that have been reported to the manufacturer.A stock clearance has been initiated and the defective products have been sorted out.Based upon the investigations results a capa was initiated - further actions will be documented.Associated medwatch-reports: 9610612-2021-00327 ((b)(4) + fh620r) and 9610612-2021-00326 ((b)(4) + pe204a).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: a foreign substance can be found on the shaft of the endoscope.Visually, no deviation can be found at the trocar.The foreign substance at the shaft is probably adhesive, most likely caused by an improper montage of the endoscope.Furthermore, the measures of the endoscope has been checked, but partially found to be not according the specification.Therefore the failure described by the customer could be simulated, a montage of the components was not possible.Batch history review: dhr check has been carried out in course the communication with the manufacturer.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of the risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is no longer acceptable.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.Specifically, it is assumed that the dimensional deviations are a manufacturing defect, which is communicated to the manufacturer and documented in the z2 messages 201974056, 201978630 and 201978631.A stock clearing was initiated and defective products were sorted out.Based upon the investigations results a product safety case (psc) was initiated.Associated medwatch-reports: 9610612-2021-00327 (400508674 + fh620r), 9610612-2021-00326 (400508675 + pe204a).

Event Description

The malfunction is filed under aag reference (b)(4).

• Brand Name: MINOP INVENT 30DG TROCAR D8.3MM L150MM
• Type of Device: NEUROENDOSCOPY
• 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: 11678918
• MDR Text Key: 245862555
• Report Number: 9610612-2021-00327
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K983365
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 52615118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 11/03/2021
• Supplement Dates FDA Received: 08/12/2021; 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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