RICHARD WOLF 5261.27 5377.105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-18 for RICHARD WOLF 5261.27 5377.105 manufactured by Richard Wolf.

Event Text Entries

[752] The richard wolf c mount lens was soaked for one hour prior to its use in coldspor. It was then rinsed with sterile water and towel dried before being hooked to scope for procedure. During the procedure, the c mount lens fogged due to moisture. This necessitated a decision to stop the laparoscopic procedure and switch to an open cholecystectomy. The patient tolerated the procedure welldevice 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, performance tests performed, visual examination. Results of evaluation: other, unanticipated, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by manufacturer/distributor representative. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1117
• MDR Report Key: 1117
• Date Received: 1992-08-18
• Date of Report: 1992-07-21
• Date of Event: 1992-07-20
• Date Facility Aware: 1992-07-20
• Report Date: 1992-07-21
• Date Reported to FDA: 1992-07-21
• Date Reported to Mfgr: 1992-07-20
• Date Added to Maude: 1992-08-24
• 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: RICHARD WOLF
• Generic Name: C MOUNT LENS/CAMERA
• Product Code: FXQ
• Date Received: 1992-08-18
• Model Number: 5261.27
• Catalog Number: 5377.105
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1070
• Manufacturer: RICHARD WOLF

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-18