MAUDE Adverse Event Report: AESCULAP AG SENSATION TUMOR GRASPER TOOTHED 2.5/90MM; MICRO-NEURO INSTRUMENTS

Model Number FM176R

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "both sensation forceps have fractures in their plastic grips." this incident did not cause or contribute to serious injury or death or a delay in surgery.No additional intervention required.All med watch submissions related to this patient are: 9610612-2019-00164.

Manufacturer Narrative

Investigation: fm176r: both gripis of the forceps are broken.Cracks can be found on the outside.On the inside, two of the four limitation stops are broken off, the fragments have not been provided.Fm178r: one grip of the forceps is broken.A crack can be found on the "sensation" labelled side.The breakage of the grips is traceable to a tensile stress above the tensile strength of the material, caused by shrinking, to be recognized by the lifted grip and the shear breakage pattern of the missing limitation stops.The yellow grips are made of coloured lovocom 1106-8085/yl- compounds based on pei (polyetherimide).Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably design related.Rationale: the selection of the material lovocim for this kind of instrument is questionable, since there are repeated problems with this kind of plastic during and after the processing process.The lifting of the grips and the shear breakage of the limitation stops are signs of a shrinkage of the material.Different thermal expansions of the different materials most likely caused a tensile stress above the tensile strenghth.Presumably, exposure time in combination with temperature during the reprocessing led to the tensile stress.Corrective action: a capa regarding the material of the grips has already been initiated and is ongoing.

• Brand Name: SENSATION TUMOR GRASPER TOOTHED 2.5/90MM
• Type of Device: MICRO-NEURO INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8392171
• MDR Text Key: 139337338
• Report Number: 9610612-2019-00163
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM176R
• Device Catalogue Number: FM176R
• Device Lot Number: 52082450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Distributor Facility Aware Date: 03/26/2019
• Device Age: 4 YR
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1