KARL STORZ 27178A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for KARL STORZ 27178A manufactured by Karl Storz.

Event Text Entries

[19233273] During cystoscopy and ureteral meatotomy one blade of scissor broke away. The scissors were removed. A guide wire was introduced and placed near the renal stone. Fluoroscopy was utilized for placement of wire and visualization of bladder and surrounding structures, no foreign body/material was noteddevice 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: invalid data. Invalid data - service records availability. 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, visual examination. Results of evaluation: end of life - expected, expected wear/deterioration. Conclusion: device discarded - unable to follow-up, device unavailable for follow-up investigation examination. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3059
• MDR Report Key: 3059
• Date Received: 1992-07-31
• Date of Report: 1992-03-05
• Date of Event: 1992-02-20
• Date Facility Aware: 1992-02-20
• Report Date: 1992-03-05
• Date Reported to Mfgr: 1992-03-05
• Date Added to Maude: 1993-04-06
• 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: KARL STORZ
• Generic Name: SCISSOR, 7 FRENCH
• Product Code: JYA
• Date Received: 1992-07-31
• Model Number: 27178A
• Catalog Number: 27178A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-JAN-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2860
• Manufacturer: KARL STORZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31