MAUDE Adverse Event Report: AESCULAP AG KAIRISON PUNCH BRACKET PRESSURE REDUCER; RONGEUR, POWERED

Model Number FK887R

Device Problem Use of Device Problem (1670)

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

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the investigation was carried out visually and a functional test was performed.The connectin pins are no longer according to the specifications, since they are deformed, most likely caused by a drop.Due to these damages, a proper mounting of the disposable tube set fk888su can no longer be guaranteed.The functional test was carried out successfully, but the set could only be assembled with high forces.Without a correct connection of the tube set, the function of the kairison bone punch will not be according to specification.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.No capa is necessary.

Event Description

Country of complaint: (b)(6).Io would not engage shaft.

• Brand Name: KAIRISON PUNCH BRACKET PRESSURE REDUCER
• Type of Device: RONGEUR, POWERED
• 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: 7790339
• MDR Text Key: 117432710
• Report Number: 9610612-2018-00347
• Device Sequence Number: 1
• Product Code: HAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062413
• 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
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK887R
• Device Catalogue Number: FK887R
• Device Lot Number: 51504186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Distributor Facility Aware Date: 07/16/2018
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other