MAUDE Adverse Event Report: AESCULAP AG ENDOSCOPIC MYOMA FIXATION INSTRUMENT; EXTRACTOR

Model Number PL430R

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: on-going.

Event Description

Device broke during use.X-ray performed.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The hardness test comfirmed the pre-set values.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed from this batch.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 related to an insufficient usage.Rational: it is almost certain that a mechanical overload situation led to the breakage.Visual investigation and hardness test indicated that the quality requirements are within the specified tolerance range.No capa is necessary.

• Brand Name: ENDOSCOPIC MYOMA FIXATION INSTRUMENT
• Type of Device: EXTRACTOR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5448841
• MDR Text Key: 38981313
• Report Number: 2916714-2016-00125
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K943603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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: No Information
• Device Model Number: PL430R
• Device Catalogue Number: PL430R
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2016
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: 01/21/2016
• Supplement Dates FDA Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other