HEZHAT-DORSEY TIM SMOKEEVAC TM TRUMPET VALVE * 5202770

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-22 for HEZHAT-DORSEY TIM SMOKEEVAC TM TRUMPET VALVE * 5202770 manufactured by Davol Inc. Subsidiary Of Cr Bard, Inc..

Event Text Entries

[142368] During a gynecologic laparoscopic surgery, device was used as irrigator/smoke evacuator. However, when not in use, the device continued to "suction. " during period of non-use device was resting on bowel, the suction then created a large hematoma on the bowel. Laparoscopic film saved.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 228752
• MDR Report Key: 228752
• Date Received: 1999-06-22
• Date of Report: 1999-06-21
• Date of Event: 1999-06-18
• Date Facility Aware: 1999-06-18
• Report Date: 1999-06-22
• Date Reported to FDA: 1999-06-22
• Date Reported to Mfgr: 1999-06-22
• Date Added to Maude: 1999-06-28
• 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
• Reporter Occupation: RISK MANAGER
• 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: HEZHAT-DORSEY TIM SMOKEEVAC TM TRUMPET VALVE
• Generic Name: IRRIGATOR/SMOKE EVACUATOR
• Product Code: FCZ
• Date Received: 1999-06-22
• Returned To Mfg: 1999-06-22
• Model Number: *
• Catalog Number: 5202770
• Lot Number: 41DJN015
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 221822
• Manufacturer: DAVOL INC. SUBSIDIARY OF CR BARD, INC.
• Manufacturer Address: 100 SOCKNOSSETT CROSSROAD CRANSTON RI 02920 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-06-22