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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-07-25 for * manufactured by *.

Event Text Entries

[8242568] Investigation: at the distributor's request, sr surgical instrument engineer, and commercial assistant, checked the instrument thoroughly, and reviewed the co's mfg records: the instrument in question was manufactured in november 2007 with lot # 0711. 30 pcs. Out of this lot were delivered to the distributor in 2007. Our electronical records allow us to trace back delivery of this item to january 2003. Since then, a large quantity of this article have been delivered to the distributor, and we have not been made aware of any other complaint of this nature so far. A thorough review of our production documents revealed no non-conformances in materials, mfg processes or any deviations whatsoever when comparing the device(s) with the master sample and/or engineering drawing. They passed the 100% quality and functional control prior to delivery. No material defects could be detected during visual inspection. The instrument was disassembled into the single components for inspection, re-assembled and tested, and we could not find any defects, malfunctions or whatever. The instrument meets all specs, and is working properly. We cannot confirm the hosp's assumption of a bent distal channel. Conclusion: no conclusion as to the exact cause for the incident described above can be drawn. However, a possible reason for the malfunction during use could be that the tonsil wire had not been inserted properly before use of the instrument. If this had been the case, the pull rod could get jammed. Based on the above investigation, we consider this to be an unjustified complaint, because the instrument meets all specs. No defect could be found and a misapplication/user error is to be assumed. Capa action required? Mfg process & design. No. Since there is no indication to assume a defect in material, mfg nor our trend analysis reflects any problems with this pattern or design, we feel that no corrective or preventive actions are to be taken at our end. The instrument in question has been returned to the distributor.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9611610-2008-00001
• MDR Report Key: 1230136
• Report Source: 08
• Date Received: 2008-07-25
• Date Mfgr Received: 2008-07-03
• Device Manufacturer Date: 2007-11-01
• Date Added to Maude: 2008-11-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: DORFSTRASSE 2
• Manufacturer City: DURCHHAUSEN 78591
• Manufacturer Country: GM
• Manufacturer Postal: 78591
• Manufacturer Phone: 4641339
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: KBZ
• Date Received: 2008-07-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1281224
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-07-25