INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-10 for INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

• Report Number: 9610773-2020-00088
• MDR Report Key: 9811852
• Report Source: COMPANY REPRESENTATIVE,DISTRI
• Date Received: 2020-03-10
• Date of Report: 2020-03-20
• Date of Event: 2020-01-02
• Date Mfgr Received: 2020-03-19
• Device Manufacturer Date: 2015-07-01
• Date Added to Maude: 2020-03-10
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. DANIEL WLADOW
• Manufacturer Street: KUEHNSTRASSE 61
• Manufacturer City: HAMBURG 22045
• Manufacturer Country: GM
• Manufacturer Postal: 22045
• Manufacturer Phone: 4940669662
• Manufacturer G1: OLYMPUS
• Manufacturer Street: KUEHNSTRASSE
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Generic Name: RESECTION?SHEATHS,?IRRIGATION?RINGS,?CYSTOSCOPE?SHEATHS,?HYSTEROSCOPE?SHEATHS
• Product Code: FJL
• Date Received: 2020-03-10
• Returned To Mfg: 2020-03-10
• Model Number: A22040A
• Catalog Number: A22040A
• Lot Number: 157W
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OLYMPUS WINTER & IBE GMBH
• Manufacturer Address: KUEHNSTRASSE 61 HAMBURG 22045 GM 22045

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-10