BERKELEY VACURETTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-02 for BERKELEY VACURETTE manufactured by Cabot Medical.

Event Text Entries

[4609] A 30-yr-old female outpt was undergoing dilatation and curettage on 8/24/93. During the procedure, the attending physician noticed that he was not obtaining any uterine contents. When he removed the device from the pt to evaluate the problem, he noted that the tip had broken off. Laparoscopy was performed; tip retrieved. Hemostat applied to uterine perforation. The pt was admitted to the hosp for observation for 24 hrs and iv antibiotics. 09/02/age on 8/24/93. During the procedure, the attending physician noticed that he was not obtaining any uterine contents. When he removed the device from the pt to evaluate the problem, he noted that the tip had broken off. Laparoscopy was performed; tip retrieved. Hemostat applied to uterine perforation. The pt was admitted to the hosp for observation for 24 hrs and iv antibioticsdevice 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: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6480
• MDR Report Key: 6480
• Date Received: 1993-09-02
• Date of Report: 1993-08-25
• Date of Event: 1993-08-24
• Date Facility Aware: 1993-08-24
• Report Date: 1993-08-25
• Date Reported to FDA: 1993-08-25
• Date Reported to Mfgr: 1993-08-25
• Date Added to Maude: 1993-09-20
• 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: BERKELEY VACURETTE
• Generic Name: 6 MM VACURE TE F TIP
• Product Code: HHI
• Date Received: 1993-09-02
• Lot Number: ZG2300
• ID Number: PAT #3506010
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6168
• Manufacturer: CABOT MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-09-02