MAUDE Adverse Event Report: SMITH & NEPHEW INC. TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72204064

Device Problems Overheating of Device (1437); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during hysteroscopy myomectomy, the blade stopped cutting while being applied uterine tissue removal.The hand piece started to heat up and became too hot to hold.The surgeon removed the blade and scope and swapped out hand piece from another kit and opened a new blade to complete the case.There was no injury caused to the patient and no medical intervention was required.

• Brand Name: TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW INC.; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer (Section G): SMITH & NEPHEW INC.; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6987359
• MDR Text Key: 91075018
• Report Number: 1643264-2017-21126
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2018
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Device Lot Number: G22287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 10/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1