2135.09

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-29 for 2135.09 manufactured by Wolf.

Event Text Entries

[15007707] During a percutaneous nephrostolithotoy procedure a 9 fr electrohydraulic lithotripter probe was used with a leaver ehc unit. When the probe was removed from the patient's kidney the end of the probe was missing from the probe. (piece is approximately 1mm x 3mm in size). The surgeon chose not to search for piece of metal at the end of the procedure because he was concerned that he would lose access to the patient's kidney since our guide wire (safety wire) had already come outdevice labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: invalid data. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no 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: 2349
• MDR Report Key: 2349
• Date Received: 1993-01-29
• Date of Report: 1992-11-10
• Date of Event: 1992-11-10
• Date Facility Aware: 1992-11-10
• Report Date: 1992-11-10
• Date Reported to FDA: 1992-11-10
• Date Reported to Mfgr: 1992-11-10
• Date Added to Maude: 1993-02-05
• 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

• Generic Name: ELECTROHYDRAULIC LITHOTRIPTER PROBE
• Product Code: FGM
• Date Received: 1993-01-29
• Model Number: 2135.09
• Lot Number: 2875
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2175
• Manufacturer: WOLF

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-29