MAUDE Adverse Event Report: AESCULAP AG FERGUSSON SUCT.CANN D:1.5MM WORK.L.200MM; INSTRUMENTS FOR NEUROSURGERY

Model Number GF380R

Device Problem Break (1069)

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 to aesculap (b)(4) that a fergusson suct.Cann d:1.5mm work.L.200mm (part # gf380r) was used during an ear, nose, throat (ent) surgery performed on an unknown date.According to the complainant, during the surgery, the needle broke.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although request, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Event Description

No patient hazard and no patient injury was reported.

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: the investigation was carried out visually.The cannula was found to be broken and deformed.Investigations lead to the assumption that the broken off and deformed cannula was caused by an improper handling due to a mechanical overload situation.Due to the long lever and thin wall thickness of the cannula, careful handling is necessary for safe use.Excessive leverage may cause the cannula to break.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: FERGUSSON SUCT.CANN D:1.5MM WORK.L.200MM
• Type of Device: INSTRUMENTS FOR NEUROSURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11673295
• MDR Text Key: 256452012
• Report Number: 9610612-2021-00303
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 04038653202317
• UDI-Public: 4038653202317
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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: GF380R
• Device Catalogue Number: GF380R
• Device Lot Number: 51711257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1