WOLF-YOON FALLOPIAN RING APPLICATOR 8376.82

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-22 for WOLF-YOON FALLOPIAN RING APPLICATOR 8376.82 manufactured by Richard Wolf, Gmbh.

Event Text Entries

[6735] Device was used for a laparoscopic tubal occlusion. Prior to surgery it was determined that everytime the technician attempted to load the instrument, it would not lock with the rings in place. After several attempts, the technician finally got the device to lock, however during surgery two (2) rings fired simultaneously onto one tube. There was no pt injury. User facility states that this instrument is between 5 a 7 years old, had not been used recently and has never been in for factory maintenance. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid 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: 1418479-1994-09056
• MDR Report Key: 9460
• Date Received: 1994-07-22
• Date of Report: 1994-07-08
• Date of Event: 1994-07-01
• Date Facility Aware: 1994-07-05
• Report Date: 1994-07-08
• Date Reported to FDA: 1994-07-08
• Date Reported to Mfgr: 1994-07-08
• Date Added to Maude: 1994-12-13
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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: WOLF-YOON FALLOPIAN RING APPLICATOR
• Generic Name: FALLOPIAN RING APPLICATOR
• Product Code: FHI
• Date Received: 1994-07-22
• Model Number: 8376.82
• Catalog Number: 8376.82
• Lot Number: E-M-I
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9113
• Manufacturer: RICHARD WOLF, GMBH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-07-22