MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. RING APPLICATOR, 45 DEGREE SET; INTRACAVITARY BRACHYTHERAPY APPLICATOR

Catalog Number GM11001220

Device Problems Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The issue was investigated and multiple issues were identified.There was a mfg issue as the quality of the gluing process carried out at the external supplier is not satisfactory.A design issue was also identified as internal testing showed that the ring probes develop hairline fractures during sterilization process (when processed as described in the current ifu).Design may not be suitable for mfg with that amount of glue.There have not been any reported incidents regarding this issue from users of the aforementioned applicator sets / components.A corrections strategy is in progress and details will be given when finalized.

Event Description

Mfr report #9612438-2014-00002 details an issue that was identified in which a ring probe was taken from stock and inspected visually.It displayed a gap between the glue and the peek of the outer tube in the area where the ring channel and the outer tube are bonded together.Add'l ring probes were examined and mfr defects were identified.These defects consist of gaps between the upper and lower "shell halves" of the ring probe, pin holes in the glue of the ring probe, and hairline cracks in the glue of the ring probe.Additionally, the sterilization process can cause cracks to form or widen.Due to their variable nature, these defects cannot be validated for efficacy of cleaning, disinfection and sterilization.As a result, use of the ring probes subjects users and pts to a risk of infection from a contaminated part.Based on varian's device applicability assessment, it was determined that the gm11001220 ring applicator, 45 degree set and its components, gm11001240 ring probe 45 degree, 30 x 36mm, gm11001230 ring probe 45 degree, diameter 26mm x 32, and gm11001250 ring probe 45 degree, diameter 35cm x 41mm are also affected by this issue.

• Brand Name: RING APPLICATOR, 45 DEGREE SET
• Type of Device: INTRACAVITARY BRACHYTHERAPY APPLICATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC. ; 3100 hansen way; palo alto CA 94304
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS HAAN GMBH; bergische strasse 16
• Manufacturer Contact: mark kattmann ; 700 harris street, ste 109; charlottesville, VA 22903 ; 4349518632
• MDR Report Key: 3745607
• MDR Text Key: 141451595
• Report Number: 9612638-2014-00003
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K983436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: GM11001220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1