B-K MEDICAL DO 0163 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-02 for B-K MEDICAL DO 0163 * manufactured by B-k Medical Systems Inc..

Event Text Entries

[374861] Doctor was using the rectosigmoidoscope to provide access for a type 2050 anorectal ultrasound transducer. Doctor noticed that when attempting to remove the obturator, there was significant resistance, indicating the obturator was pulling a vacuum. Doctor feels there is a risk of pulling part of the intestine into the rectosigmoidoscope and injuring the patient. It is our opinion that some kind of channel or vent is needed to prevent a vacuum when the obturator is removed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 559053
• MDR Report Key: 559053
• Date Received: 2004-12-02
• Date of Report: 2004-12-02
• Date of Event: 2004-11-22
• Report Date: 2004-12-02
• Date Reported to FDA: 2004-12-02
• Date Added to Maude: 2004-12-14
• 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: 3
• 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 Sequence Number: 1

• Brand Name: B-K MEDICAL
• Generic Name: RECTOSIGMOIDOSCOPE
• Product Code: FAM
• Date Received: 2004-12-02
• Model Number: DO 0163
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 548749
• Manufacturer: B-K MEDICAL SYSTEMS INC.
• Manufacturer Address: 250 ANDOVER STREET WILMINGTON MA 01887 US

Device Sequence Number: 2

• Brand Name: B-K MEDICAL
• Generic Name: RECTOSIGMOIDOSCOPE
• Product Code: FAM
• Date Received: 2004-12-02
• Model Number: DO 0165
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 548750
• Manufacturer: B-K MEDICAL SYSTEMS, INC.
• Manufacturer Address: 250 ANDOVER STREET WILMINGTON MA 01887 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-02