MAUDE Adverse Event Report: AESCULAP AG & CO. KG FILTER RETENTION PLATE; FILTER HOLDER ON STERILIZATION COUNT

Model Number JK100

Device Problem Unintended Movement (3026)

Patient Problem Not Applicable (3189)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The filter holder does not hold.Incident has occurred several times.

Manufacturer Narrative

Manufacturing site evaluation: received product found to be conforming to specification.Few weeks ago several filter holders with this failure occurred in france.Two were sent in for investigation and were found to be fully according to the specifications.There are no other complaints like these.In 2010 the sealing lip was changed.Result: improvement of the sealing capacity.No other changes have been carried out regarding this product.There are no hints for material or product deviations.Issue attributed to handling.

• Brand Name: FILTER RETENTION PLATE
• Type of Device: FILTER HOLDER ON STERILIZATION COUNT
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; DA 78532
• Manufacturer (Section G): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 3810498
• MDR Text Key: 18922301
• Report Number: 2916714-2014-00235
• Device Sequence Number: 1
• Product Code: FRG
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK100
• Device Catalogue Number: JK100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other