ETHICON TSW35 35MM VASCULAR/THIN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-13 for ETHICON TSW35 35MM VASCULAR/THIN * manufactured by Ethicon Endo-surgery, Inc..

Event Text Entries

[17037277] The 35mm vascular stapler wouldn't fire on the fourth relead. The endopouch came apart when inserted into the abdomen. A second endopouch came apart when inserted into the abdomen.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021319
• MDR Report Key: 320644
• Date Received: 2001-03-13
• Date of Report: 2001-02-20
• Date of Event: 2001-02-14
• Date Added to Maude: 2001-03-19
• Event Key: 0
• Report Source Code: Voluntary 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: RISK MANAGER
• 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
• Generic Name: ETS ENDOSCOPIC LINEAR CUTTER
• Product Code: KOG
• Date Received: 2001-03-13
• Model Number: TSW35 35MM VASCULAR/THIN
• Catalog Number: *
• Lot Number: N4JV5K
• ID Number: *
• Device Expiration Date: 2001-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 310167
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH 452422839 US

Device Sequence Number: 2

• Brand Name: ETHICON
• Generic Name: ENDOPOUCH PRO
• Product Code: KDW
• Date Received: 2001-03-13
• Model Number: PRO46
• Catalog Number: *
• Lot Number: 00J527
• ID Number: *
• Device Expiration Date: 2001-10-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 310169
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH 452422839 US

Device Sequence Number: 3

• Brand Name: ETHICON
• Generic Name: ENDOPOUCH PRO
• Product Code: KDW
• Date Received: 2001-03-13
• Model Number: PRO46
• Catalog Number: *
• Lot Number: 00K568
• ID Number: *
• Device Expiration Date: 2001-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 310171
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH 452422839 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-03-13