2137

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-06 for 2137 manufactured by Richard Wolf Medical Instruments Inc..

Event Text Entries

[3937] On 5/3/93 63 year old in for elective turp, lithotripsy. Bladder stone. Procedure proceeding without complications, when lithotripsy machine suddenly stopped working. All combinations of cord adjustments were made without success. Other equipment being used did not affect the functioning of this unit. Patient had to return to the or on 5/14/93 for complication of surgery. Equipment sent to bio-medical engineer for assessment and repair. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: other. 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. Results of evaluation: component failure, electrical problem, invalid data. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7696
• MDR Report Key: 7696
• Date Received: 1994-01-06
• Date of Report: 1993-06-14
• Date of Event: 1993-05-13
• Date Facility Aware: 1993-05-13
• Report Date: 1993-06-14
• Date Reported to Mfgr: 1993-06-14
• Date Added to Maude: 1994-05-10
• 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: LITHOTRIPTOR
• Product Code: FGK
• Date Received: 1994-01-06
• Model Number: 2137
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7375
• Manufacturer: RICHARD WOLF MEDICAL INSTRUMENTS INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-06