ETHICON-ENDO SURGERY, INC. *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-12 for ETHICON-ENDO SURGERY, INC. * manufactured by Ethicon-endo Surgery, Inc..

Event Text Entries

[337758] Add'l info rec'd from mfr 4/13/2004: there was no documentation in system referring to this incident. The account was contacted and the account stated that they had reported the event to the fda and not ees. Mfr has entered the info for the mst11 lot #r4uz73 and mset lot #03a133 provided from your report into mfr's system and assigned it sr #362683-0. It has been documented in the file sr #362683-0 that the account nurse had agreed during the in-service with the ees sale rep that they had been positioning the system too far from the fisher table during firing of the probe. This position caused the vacuum insertion tube to the probe to snap and break off. In addition a second mst11 probe was used to complete the case successfully. There was no consequence to the pt and the pt was released in normal post op condition. It was confirmed by the account that the mst11 was disposed of after the procedure at the account. This issue was discussed during the in-service and agreed upon that this was a user error and has been corrected by add'l training during the reps in-service. There was no product returned for evaluation and analysis therefore there are no conclusions as to what may have caused the event from that process. A lot history review has been done and noted in the attached sr analysis report #362683-0. There has been no medwatch filed as this complaint does not meet the definition of a reportable event and considered not reportable.
Patient Sequence No: 1, Text Type: D, B5

[357685] Procedure right stereotactic breast biopsy with mammotome machine. Ethicon endo-surgery, inc. Mammomtome st stereotactic probe 11 gauge, has a vacuum set attached to it at 2 different sites. In mid procedure the site of vacuum insertion to probe snapped and broke off. The procedure had to be halted. Needle removed from pt's breast. Pressure applied to site while changing probe and vacuum set.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030544
• MDR Report Key: 503142
• Date Received: 2003-12-12
• Date of Report: 2003-12-12
• Date of Event: 2003-12-11
• Date Added to Maude: 2003-12-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ETHICON-ENDO SURGERY, INC.
• Generic Name: STEREOTACTIC PROBE 11 GAUGE
• Product Code: HAW
• Date Received: 2003-12-12
• Returned To Mfg: 2003-12-12
• Model Number: *
• Catalog Number: *
• Lot Number: R4UZ73
• ID Number: *
• Device Expiration Date: 2003-11-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 491915
• Manufacturer: ETHICON-ENDO SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH * US

Device Sequence Number: 2

• Brand Name: ETHICON-ENDO SURGERY, INC.
• Generic Name: VACUUM SET MAMMOTOME
• Product Code: FCK
• Date Received: 2003-12-12
• Returned To Mfg: 2003-12-12
• Model Number: *
• Catalog Number: *
• Lot Number: 03A133
• ID Number: *
• Device Expiration Date: 2008-04-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 492232
• Manufacturer: ETHICON-ENDO SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-12