HYDRO SURG IRRIGATOR * P35024P13

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-19 for HYDRO SURG IRRIGATOR * P35024P13 manufactured by Davol, Inc, A Div Of C.r. Bard Inc..

Event Text Entries

[15004077] Hydrosurg was on but would not run. Pistol hand control would not allow fluids to flow. No further details on the incident are available and the pt outcome is unknown. Device usage problem: not known.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 512101
• MDR Report Key: 512101
• Date Received: 2004-02-19
• Date of Report: 2003-11-01
• Date of Event: 2003-11-01
• Date Added to Maude: 2004-02-20
• 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
• 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: HYDRO SURG IRRIGATOR
• Generic Name: HYDRO SURG LAPAROSCOPIC IRRIGATOR
• Product Code: KQT
• Date Received: 2004-02-19
• Model Number: *
• Catalog Number: P35024P13
• Lot Number: T4XF6J
• ID Number: *
• Device Expiration Date: 2008-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 501089
• Manufacturer: DAVOL, INC, A DIV OF C.R. BARD INC.
• Manufacturer Address: 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US

Device Sequence Number: 2

• Brand Name: ENDOPATH PROBE PLUS II
• Generic Name: PISTOL HAND CONTROL
• Product Code: EYN
• Date Received: 2004-02-19
• Returned To Mfg: 2003-11-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 515450
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: 4545 CREEK ROAD CINCINNATI OH 45242 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-02-19