OLYMPUS A2636 83A2636

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-01 for OLYMPUS A2636 83A2636 manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[17514044] The customer returned an obturator because the tip of the obturator was locked in an angled position and would not straighten.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610773-1998-00013
• MDR Report Key: 175215
• Report Source: 05
• Date Received: 1998-07-01
• Date of Report: 1998-06-25
• Date Mfgr Received: 1998-06-11
• Date Added to Maude: 1998-07-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OLYMPUS
• Generic Name: OBTURATOR
• Product Code: FEC
• Date Received: 1998-07-01
• Returned To Mfg: 1998-03-05
• Model Number: A2636
• Catalog Number: 83A2636
• Lot Number: 73W
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 170367
• Manufacturer: OLYMPUS WINTER & IBE GMBH
• Manufacturer Address: KUEHNSTRASSE 61 HAMBURG GM 22045
• Baseline Brand Name: OLYMPUS
• Baseline Generic Name: OBTURATOR
• Baseline Model No: A2636
• Baseline Catalog No: 83A2636
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K931995
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-07-01