CUTTING LOOP, BIPOLAR, 24/26 FR 27040GP1-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-07 for CUTTING LOOP, BIPOLAR, 24/26 FR 27040GP1-S manufactured by Karl Storz Se & Co. Kg.

MAUDE Entry Details

• Report Number: 9610617-2020-00018
• MDR Report Key: 9681781
• Report Source: USER FACILITY
• Date Received: 2020-02-07
• Date of Report: 2020-02-06
• Date of Event: 2020-01-09
• Date Mfgr Received: 2020-01-14
• Device Manufacturer Date: 2019-06-01
• Date Added to Maude: 2020-02-07
• 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: MRS. SUSIE CHEN
• Manufacturer Street: 2151 E. GRAND AVENUE
• Manufacturer City: EL SEGUNDO CA 90245
• Manufacturer Country: US
• Manufacturer Postal: 90245
• Manufacturer Phone: 4242188201
• Manufacturer G1: KARL STORZ SE & CO.KG
• Manufacturer Street: DR.-KARL-STORZ -STRASSE 34 78532
• Manufacturer City: TUTTLINGEN, GM,
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR
• Generic Name: BIPOLAR SINGLE USE CUTTING LOOP
• Product Code: FAS
• Date Received: 2020-02-07
• Returned To Mfg: 2020-01-27
• Model Number: 27040GP1-S
• Catalog Number: 27040GP1-S
• Lot Number: WQ12
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ SE & CO. KG
• Manufacturer Address: DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM,

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-07