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

Model Number TBD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cancer (3262)

Event Date 04/04/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Traumatic injury legal claim received states the following: on (b)(6) 2010 patient underwent exploratory laparotomy involving numerous surgical procedures at which time there was no evidence of residual disease.On (b)(6) 2010 after staging 3 cycles of chemotherapy a pet scan revealed a large lower pelvic mass.On (b)(6) 2010, patient underwent exploratory laparotomy.The surgeon had to remove multiple tumors in the abdominal and pelvic region and resection of recto sigmoid colon.After this procedure, her disease continued to spread and she succumbed to her illness on (b)(6) 2011.Among other devices identified, the laparoscopic power morcellator was identified as being utilized at some time during the surgical procedures.It is unknown at this time if any of smith & nephew devices were used.

• Brand Name: TBD
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5635849
• MDR Text Key: 44550646
• Report Number: 3003604053-2016-00015
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 04/29/2016

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: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/05/2016
• 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