MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR RECIPRCATING MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); Death (1802); No Code Available (3191)

Event Date 05/14/2015

Event Type  Death  

Event Description

During a myomectomy ¿ removal of two fibroids, it was reported that the fluid absorption was high during the procedure.At a fluid deficit of 2500cc, the doctor was asked if the case would be concluded based on the fluid deficit.The doctor elected to complete the procedure.The tissue removal procedure ran normal.Once they started pulling back the truclear tower, the staff started to surround the patient.The patient coded.The laparoscopic portion of procedure was cancelled.The patient expired in the operating room.Fluid management devices that could have been used in the procedure (related complaint (b)(4)): hysteroscopic fluid monitor system ref: 7210165 sn: (b)(4).Vacuum regulator model: pm3600 sn: (b)(4).Truclear control unit ref: 7209808 sn: (b)(4).Footpedal ref: 7209820 sn: (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: TRUCLEAR RECIPRCATING MORCELLATOR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4841440
• MDR Text Key: 18654559
• Report Number: 3003604053-2015-00029
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR