VALLEY LAB SSE2J N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-31 for VALLEY LAB SSE2J N/A manufactured by Valley Lab.

Event Text Entries

[1] Om 01-10-92 patient had an elective colonoscopy without apparent injury or incident. Patient was recovered and discharged home. Returned on 1/11/92 with abdominal pain, taken to surgery, exploratory lap, post-op dx perforated bowel. A valley lab cautery unit was used for the colonoscopy unit #00680, the setting were coag=2; cutting=0, a non disposable hot biopsy forceps was used. The cautery unit was checked by bio-med after the second incident on 1/10/92. The unit was found to meet the manufacturer's specificationsdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Device serviced in accordance with service schedule. Date last serviced: 01-jul-91. 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: none or unknown, inherent risk of procedure, unanticipated short term complication of procedure. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 66
• MDR Report Key: 66
• Date Received: 1992-01-31
• Date of Report: 1992-01-17
• Date of Event: 1992-01-10
• Date Facility Aware: 1992-01-11
• Report Date: 1992-01-17
• Date Reported to FDA: 1992-01-17
• Date Reported to Mfgr: 1992-01-13
• Date Added to Maude: 1992-03-24
• 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: VALLEY LAB
• Generic Name: ELECTROCAUTERY GENERATOR
• Product Code: HIM
• Date Received: 1992-01-31
• Model Number: SSE2J
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 64
• Manufacturer: VALLEY LAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-01-31