OLYMPUS LITHOTRIPSER BASKET NOT KNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for OLYMPUS LITHOTRIPSER BASKET NOT KNOWN manufactured by Olympus Corporation.

Event Text Entries

[17417166] Admitted because of obstructive jaundice and found to have gallstones with multiple common duct stones. Attempt was made to extract the common duct stones via an endoscopic retrograde cholangiopancreatogram and this was partially successful. While using the balloon extractor closing down basket, the wires broke off in the handle with the basket still around the stone basket was retrieved using another type of stone crusher. Additional stones remained in the common duct and after surgical consultation an open cholecystectomy was performed. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair 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: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 21526
• MDR Report Key: 21526
• Date Received: 1993-08-02
• Date of Report: 1993-02-09
• Date of Event: 1992-10-29
• Date Facility Aware: 1992-10-29
• Report Date: 1993-02-09
• Date Reported to Mfgr: 1992-10-30
• Date Added to Maude: 1995-04-24
• 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: OLYMPUS LITHOTRIPSER BASKET
• Product Code: FGK
• Date Received: 1993-08-02
• Model Number: NOT KNOWN
• ID Number: NOT KNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 21568
• Manufacturer: OLYMPUS CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-02