MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR HYSTEROSCOPIC MORCELLATION SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72202734

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

Patient Problem Perforation (2001)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Due to the device not being returned, we are unable to determine if the device may have caused or contributed to the reported incident.In the event the sample is returned for evaluation the complaint will be reopened for additional investigation.No further investigation is necessary at this time.(b)(4).

Event Description

It was reported that the operative hysteroscopy set and system were used in a hysterscopic myomectomy procedure in which a uterus perforation was discovered.The perforated uterus resulted in an emergent open laparotomy.No post-operative patient information is available at this time.

Manufacturer Narrative

Event required intervention to prevent permanent impairment/damage.Evaluation narrative - the subject device, intended for treatment, and the serial number were not made available to the designated complaint unit for evaluation.Thus, no product evaluation or review of the device history records could be performed.Any contribution of the subject device to this event and a root cause could not be determined with confidence.(b)(4).

• Brand Name: TRUCLEAR HYSTEROSCOPIC MORCELLATION SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5252959
• MDR Text Key: 32233341
• Report Number: 1643264-2015-00187
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

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: Health Professional
• Device Catalogue Number: 72202734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 11/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention