BIPOLAR PROBE 7F 000397

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-03 for BIPOLAR PROBE 7F 000397 manufactured by Everest Medical.

Event Text Entries

[3463] The nurse states that on 4/22/93, a female patient (unknow age) presented for gastric hemostatis. Tehprobe was placed down the endoscope's channel and as it exited the scope the probe's tip came off into the patient's stomach. The physician attempted to retreive the tip but the tip had positioned itself in the small bowel and could not be retreived. The physician antipates the tip will pass naturally. The patient remained in teh hospital for observationdevice labeled for single use. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 32838-1993-00075
• MDR Report Key: 5457
• Date Received: 1993-06-03
• Date of Report: 1993-05-04
• Date of Event: 1993-04-22
• Date Facility Aware: 1993-04-22
• Report Date: 1993-05-04
• Date Reported to Mfgr: 1993-04-26
• Date Added to Maude: 1993-07-13
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• 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 Details

• Brand Name: BIPOLAR PROBE 7F
• Generic Name: PROBE
• Product Code: FGM
• Date Received: 1993-06-03
• Model Number: 000397
• Lot Number: NB922101
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 5153
• Manufacturer: EVEREST MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-03