STORZ MEDICAL ACME TRANSFORMER GP TRANSFORMER T-1-81052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for STORZ MEDICAL ACME TRANSFORMER GP TRANSFORMER T-1-81052 manufactured by Storz Medical.

Event Text Entries

[341480] A lithrotripsy was discovered to have a problem so the procedure was cancelled. A technician touched an anesthesia cart and the lithrotripsy table at the same time and received an electrical shock. An investigation revealed that a vendor-made adaptor cord was improperly wired (the hot (white) wire was connected to the common terminal in the ground plug. The green/ground wire in the cord was connected to one of the 120v terminals in the plug.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030347
• MDR Report Key: 500906
• Date Received: 2003-11-24
• Date of Report: 2003-11-24
• Date of Event: 2003-11-14
• Date Added to Maude: 2003-12-16
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STORZ MEDICAL
• Generic Name: LITHROTRIPSY TABLE
• Product Code: LNS
• Date Received: 2003-11-24
• Model Number: ACME TRANSFORMER GP TRANSFORMER
• Catalog Number: T-1-81052
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 489675
• Manufacturer: STORZ MEDICAL
• Manufacturer Address: * * US

Device Sequence Number: 2

• Brand Name: PRIME MED SVS
• Generic Name: ADAPTOR CORD
• Product Code: FFZ
• Date Received: 2003-11-24
• Model Number: ACME TRANSFORMER GP TRANSFORMER
• Catalog Number: T-1-81052
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 489677
• Manufacturer: PRIME MEDICAL SERVICES
• Manufacturer Address: 1301 CAPITOL OF TEXAS HWY SUITE B-200 AUSTIN TX 78746 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-11-24