MAUDE Adverse Event Report: AESCULAP AG FERG-FRAZIER SUCT 9FR 3/110MMWRK-LGTH; INSTRUMENTS FOR NEUROSURGERY

Model Number GF353R

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 gf353r - ferg-frazier suct 9fr 3/110mmwrk-lgth.According to the complaint description, during a surgery, as the cannulas were used in the usual way, they broke supposedly without any force exerted from the medic and almost falling inside the operating field.Each cannula was, allegedly, broken at different procedures and used by different doctors.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00284 ((b)(4)), ((b)(4)), 9610612-2021-00271 ((b)(4)).

Event Description

Associated medwatch-reports: 9610612-2021-00272 (400506559 + gf353r), 9610612-2021-00271 (400506557 + gf352r).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: FERG-FRAZIER SUCT 9FR 3/110MMWRK-LGTH
• Type of Device: INSTRUMENTS FOR NEUROSURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11554012
• MDR Text Key: 244436916
• Report Number: 9610612-2021-00272
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• 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: 08/04/2021

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: GF353R
• Device Catalogue Number: GF353R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1