MAUDE Adverse Event Report: AESCULAP AG FERG-FRAZIER SUCT 6FR 2/110MM WRK-LGTH; MICRO NEUROSURGICAL INSTR. / D

Model Number GF351R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the frazier suction.It was reported that the tip of the instrument broke off during the first insertion.There was no patient harm.An additional medical intervention was not necessary.Additional information was not provided.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: due to the clarifcation,the report was reassessed and found to no longer require submission - no mulfunction or serious injury.Manufacturing side evaluation: we received a complaint about an intraoperatively broken suction instrument.Statement of the customer.During the first insertion, the tip was damaged, broke off.The instrument arrived with the broken off part in a decontaminated condition and it is available for investigation.Consequences for the patient: unknown.Information has been requested at the clinic at least three times.Investigation: the instrument arrived in a clean status with the broken off tube gf351203.The investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".We made a visual inspection of the instrument.Here we found a bent and deformed mandrin.We also detected a bent and deformed tube gf351203.Additionally we discovered an unknown labeling.Furthermore we found cracks and brown discolorations.Batch history review: the device history records (dhr) have been checked for the available lot number(s) and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing error or a material failure.One similar incident have been filed with a product from the same lot number.Conclusion and root cause: the failure is most probably usage related.Rationale: according to the quality standard and dhr files, a material defect and production error can be excluded.Investigations lead to the assumption that the broken off tube was caused by an improper handling due to a mechanical overload situation.The bent and deformed tube is an additional sign for a mechanical overload situation.It could be that the brown discoloration is rust.The cause for the unknown labeling could not be determined.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: FERG-FRAZIER SUCT 6FR 2/110MM WRK-LGTH
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9528475
• MDR Text Key: 179470002
• Report Number: 9610612-2019-00864
• Device Sequence Number: 1
• Product Code: GEA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF351R
• Device Catalogue Number: GF351R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1