MAUDE Adverse Event Report: AESCULAP AG KAIRISON PNEUM.PUNCH PRESSURE REDUCER RONGEUR, POWERED

Model Number FK898R

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 no engage shaft.

• Brand Name: KAIRISON PNEUM.PUNCH 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: 7790323
• MDR Text Key: 117438410
• Report Number: 9610612-2018-00310
• 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

• 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

• Device Model Number: FK898R
• Device Catalogue Number: FK898R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 07/16/2018
• Event Location: No Information
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/16/2018 Patient Sequence Number: 1