KARL STORZ 28162FL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-12 for KARL STORZ 28162FL manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[447894] Piece of biopsy forceps came off instrument and lodged in pt's brain or soft tissue and was not retrieved. Upon follow up the risk mgr, we learned that the doctor did, in fact, retrieve the broken piece during same procedure. In 2006, mri was performed and came back negative. Mri also confirmed there was no adverse effect on pt due to breakage. Original procedure completed with no adverse effect on pt; pt condition post-op and later when he returned for suture removal was fine.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2020550-2006-00029
• MDR Report Key: 715030
• Date Received: 2006-05-12
• Date of Report: 2006-05-12
• Date of Event: 2006-03-23
• Date Facility Aware: 2006-04-12
• Report Date: 2006-05-12
• Date Reported to FDA: 2006-05-12
• Date Reported to Mfgr: 2006-05-12
• Date Added to Maude: 2006-05-18
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KARL STORZ
• Generic Name: BIOPSY FORCEPS
• Product Code: DWZ
• Date Received: 2006-05-12
• Model Number: 28162FL
• Catalog Number: 28162FL
• Lot Number: FG
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 34 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 704096
• Manufacturer: KARL STORZ GMBH & CO. KG
• Manufacturer Address: * TUTTLINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-05-12