KARL STORZ 260006BA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-11 for KARL STORZ 260006BA manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[745034] This mdr is based on preliminary info rec'd, has not conclusively determined the cause of the adverse event. During a lap sigmoid resection, the surgeon delayed the case due to the "graininess" on the monitor. The or mgr swapped out the camera ccu, camera head, and telescope, but the complaint was not resolved and the picture remained pixelated. The dr made the decision to abandon the laparoscopy procedure and perform open surgery. The hosp reported that there was no adverse effect to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2020550-2007-00010
• MDR Report Key: 978641
• Date Received: 2007-05-11
• Date of Report: 2007-05-10
• Date of Event: 2007-04-04
• Date Facility Aware: 2007-04-10
• Report Date: 2007-05-10
• Date Reported to FDA: 2007-05-10
• Date Reported to Mfgr: 2007-05-10
• Date Added to Maude: 2008-01-15
• 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
• 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: HOPKINS II TELESCOPE
• Product Code: HKK
• Date Received: 2007-05-11
• Model Number: 260006BA
• Catalog Number: 260006BA
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 1 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 946491
• Manufacturer: KARL STORZ GMBH & CO. KG
• Manufacturer Address: * TUTTLINGEN * GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-05-11