PAD = POLYHESIVE II ESU=FORCE 2 & SSE2L PAD+E7507

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-18 for PAD = POLYHESIVE II ESU=FORCE 2 & SSE2L PAD+E7507 manufactured by Valley Labs.

Event Text Entries

[1716] Doctor was doing laproscopic surgery when vessel began to bleed. No cautery with esu force 2 unit. While doctor mechanically clamped vessel, force 2 esu was removed and sse2l esu connected to existing instruments. Still no cautery - polyhesive ii ground pad replaced with new pad. Doctor able to acheive monopolar cautery. No alarms from either esu unit to signal pad or connection problem. Patient bled approximately 400cc-required 2 day hospital stay and blood transfusion. Discharged stableinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: telemetry failure, none or unknown, none or unknown, none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: no. Corrective actions: device returned to manufacturer/dealer/distributor, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2461
• MDR Report Key: 2461
• Date Received: 1993-01-18
• Date of Report: 1992-07-09
• Date of Event: 1992-06-30
• Date Facility Aware: 1992-06-30
• Report Date: 1992-07-09
• Date Reported to FDA: 1992-07-09
• Date Reported to Mfgr: 1992-06-30
• Date Added to Maude: 1993-03-09
• 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: 0
• Initial Report to FDA: 0
• 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: PAD = POLYHESIVE II
• Generic Name: ESU & CAUTERY PAD
• Product Code: HIM
• Date Received: 1993-01-18
• Model Number: ESU=FORCE 2 & SSE2L
• Catalog Number: PAD+E7507
• Lot Number: -11AF LOT=PAD=K0175-3
• ID Number: FORCE 2= 014260/SSE2L=8410
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2287
• Manufacturer: VALLEY LABS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-18