MAUDE Adverse Event Report: AESCULAP AG ELAN 4 2-RING CRANIOTOME CUTTER STANDARD; HIGH SPEED POWER SYSTEMS

Model Number GP352R

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Some material was torn out from the craniotome cutter gp352r it was afraid that those torn-out tuffs were left inside patient body.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: the failure is most likely usage related.Rational: due to the fact that we did not receive the product, a clear conclusion can not be drawn.Also the quality of the provided pictures is inadequate to evaluate this case sufficiently.Based on our experience, we assume that this maybe an overload situation (bending), in combination with wear and tear, led to the mentioned failure pattern.The cutter has to be checked prior to use, according to our ifu.No capa is necessary.

• Brand Name: ELAN 4 2-RING CRANIOTOME CUTTER STANDARD
• Type of Device: HIGH SPEED POWER SYSTEMS
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7578460
• MDR Text Key: 110462284
• Report Number: 9610612-2018-00224
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GP352R
• Device Catalogue Number: GP352R
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2018
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other