* 7550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-25 for * 7550 manufactured by Conmed Corporation.

Event Text Entries

[833712] The conmed model 7550 argon beam coagulator (abc) was used during a colonoscopy procedure to repair a bleed in the bowel. Several attempts were made to coagulate the tissue without success. In addition, the video image on the sony lmd1950md display would become distorted then blackout with an error message. The error reads no rgb connection. The video image returns to normal when the abc energy output is turned off at the foot switch. The colonoscopy procedure was completed using this same device in the bipolar mode. The video system worked fine during the use of bipolar.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1038066
• MDR Report Key: 1038066
• Date Received: 2008-04-25
• Date of Report: 2008-04-08
• Date of Event: 2008-03-29
• Report Date: 2008-04-08
• Date Reported to FDA: 2008-04-25
• Date Added to Maude: 2008-05-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• 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 Sequence Number: 1

• Brand Name: *
• Generic Name: GENERATOR, ESU, ARGON BEAM
• Product Code: GEI
• Date Received: 2008-04-25
• Model Number: 7550
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1005870
• Manufacturer: CONMED CORPORATION
• Manufacturer Address: 525 FRENCH ROAD UTICA NY 13502 US

Device Sequence Number: 2

• Brand Name: PENTAX
• Generic Name: VIDEO PROCESSOR
• Product Code: FTS
• Date Received: 2008-04-25
• Model Number: EPK-700
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 7.5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1005871
• Manufacturer: PENTAX MEDICAL COMPANY
• Manufacturer Address: 102 CHESTNUT RIDGE ROAD MONTVALE NJ 07645 US

Device Sequence Number: 3

• Brand Name: PENTAX
• Generic Name: ENDOSCOPE
• Product Code: KOG
• Date Received: 2008-04-25
• Model Number: EC-3830LK
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 7.5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 1005872
• Manufacturer: PENTAX MEDICAL COMPANY
• Manufacturer Address: 102 CHESTNUT RIDGE ROAD MONTVALE NJ 076451856 US

Device Sequence Number: 4

• Brand Name: SONY
• Generic Name: VIDEO DISPLAY
• Product Code: FTS
• Date Received: 2008-04-25
• Model Number: LMD1950MD
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 1005873
• Manufacturer: SONY
• Manufacturer Address: 1 SONY DRIVE MAIL DROP 3E6 PARK RIDGE NJ 076568003 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-04-25