HEAT PROBE CD-20Z 54331

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for HEAT PROBE CD-20Z 54331 manufactured by Olympus Corporation.

Event Text Entries

[2296] On 2/21/92, a sixty-two year old female was admitted for endoscopic management of rectal bleeding. The patient's medical history included diverticulosis and cecal angiodysplasia. Undee iv-concious sedation, heater-probe coagulation with olympus hpu healt probe unit and olympus cd heat probe of five (5) arteriovenous malformations in the cecum, and excision via cautery snare of an eight (8mm) sigmoid polyp were performed. The procedure was atraumatic and the patient tolerated it well. She was discharged in stable condition approximately three hours later. The following day, the patient experienced sudden spreading pelvic-vaginal pain and after readmission to the hospital, she was transferred to the operating room. Exploratory laparotomy, abdominal lavage and suture imbrications of cecal perforations were performed. In conclusion, specific cause for this occurrence is unknown. No equipment defect/malfunction or diviation from standard practice of patient care rendered by physician or hospital staff were found to have occurred. At the resent time, the patient is stable and recuperating at home, having beed discharged on the thirteenth post-operative daydevice not labeled for single use. 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-feb-92. Service provided by: other. Service records not 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. Conclusion: no failure detected and product within specification, none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service, none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3202
• MDR Report Key: 3202
• Date Received: 1992-07-06
• Date of Report: 1992-03-17
• Date of Event: 1992-02-21
• Date Facility Aware: 1992-02-22
• Report Date: 1992-03-17
• Date Reported to Mfgr: 1992-03-05
• Date Added to Maude: 1993-04-12
• 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: HEAT PROBE
• Generic Name: HAT PROBE CATHETER FOR REGULAR CHANNEL
• Product Code: EXX
• Date Received: 1992-07-06
• Model Number: CD-20Z
• Catalog Number: 54331
• Lot Number: UNKNOWN
• ID Number: 75020
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-APR-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2987
• Manufacturer: OLYMPUS CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-06