FMS REF 4114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-28 for FMS REF 4114 manufactured by Fms (future Medical Systems).

Event Text Entries

[17104909] Pt was undergoing a right arthroscopic debridement. Following the procedure, 5 to 6 small burns covering about a 4-inch by 4-inch area on the left inner medial thigh were noted. Burns are 2nd degree to full thickness that the plastic surgeon believes will heal with minimal scarring. The size and shape of the burns is consistent with the end of a metal rod that is used to immobilize the operative knee during the procedure. It was noted during the procedure that the pt "jumped" each time the shaver was activated. Initial investigation has revealed high micro leakage readings (. 987 ohms and 1181 ma) at future medical systems (fms)/stryker interface connector. (this interfaces the stryker 12k shaver with the fms irrigation/distention system). It was noted that the power cord was not fully seated, and when fully seated, the leakage and ground leakage dropped to. 235 ohms and 250 ma. Stryker has evaluated their equipment on site and found no problems.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 476197
• MDR Report Key: 476197
• Date Received: 2003-07-28
• Date of Report: 2002-10-01
• Date of Event: 2000-09-01
• Date Added to Maude: 2003-08-08
• 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: 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 Sequence Number: 1

• Brand Name: FMS
• Generic Name: SHAVER INTERFACE
• Product Code: HRX
• Date Received: 2003-07-28
• Model Number: REF 4114
• Catalog Number: REF 4114
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 465023
• Manufacturer: FMS (FUTURE MEDICAL SYSTEMS)
• Manufacturer Address: 504 MCCORMICK DRIVE; SUITE T GLEN BERNIE MD 21061 US

Device Sequence Number: 2

• Brand Name: STRYKER
• Generic Name: SHAVER HANDPIECE
• Product Code: HRX
• Date Received: 2003-07-28
• Model Number: 275-701-500
• Catalog Number: 12K SHAVER
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 486307
• Manufacturer: STRYKER ENDOSCOPY
• Manufacturer Address: 5900 OPTICAL CT SAN JOSE CA 95138 US

Device Sequence Number: 3

• Brand Name: FMS (FUTURE MEDICAL SYSTEMS)
• Generic Name: DUAL PUMP SYSTEM
• Product Code: HRX
• Date Received: 2003-07-28
• Model Number: FMS DUO
• Catalog Number: REF 5100-1
• Lot Number: *
• ID Number: 35631380
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 486308
• Manufacturer: FMS (FUTURE MEDICAL SYSTEMS)
• Manufacturer Address: 504 MCCORMICK DRIVE SUITE T GLEN BERNIE MD 21061 US

Device Sequence Number: 4

• Brand Name: TRINITRON
• Generic Name: COLOR VIDEO MONITOR
• Product Code: FWB
• Date Received: 2003-07-28
• Model Number: PVM-20M2MDU
• Catalog Number: *
• Lot Number: *
• ID Number: 1519159
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 486310
• Manufacturer: SONT ELECTRONICS CORP
• Manufacturer Address: 680 KINDERMACK RD ORAVELL NJ 07643 US

Device Sequence Number: 5

• Brand Name: STRYKER
• Generic Name: LIGHT SOURCE
• Product Code: FSY
• Date Received: 2003-07-28
• Model Number: X-6000
• Catalog Number: *
• Lot Number: *
• ID Number: 35631211
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 486311
• Manufacturer: STRYKER ENDOSCOPY
• Manufacturer Address: 5900 OPTICAL COURT SAN JOSE CA 95051 US

Device Sequence Number: 6

• Brand Name: TPS (TOTAL PERFORMANCE SYSTEM)
• Generic Name: SHAVER CONSOLE
• Product Code: HRX
• Date Received: 2003-07-28
• Model Number: TPS CONSOLE
• Catalog Number: *
• Lot Number: *
• ID Number: 35631206
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 486312
• Manufacturer: STRYKER INSTRUMENTS
• Manufacturer Address: 5900 OPTICAL CT SAN JOSE CA 95138 US

Device Sequence Number: 7

• Brand Name: STRYKER
• Generic Name: DIGITAL CAMERA UNIT (3 CHIP)
• Product Code: FXM
• Date Received: 2003-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 7
• Device Event Key: 486313
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2003-07-28