MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72204064

Device Problems Break (1069); Mechanics Altered (2984)

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

Event Date 09/07/2017

Event Type  malfunction  

Event Description

According to the reporter, during polypectomy, the device began to take a few bites out of the fibroid before no longer making any further progress during resection of submucosal myoma.After multiple attempts from different angles, the blade would either get stuck, slowly close cutting window.The surgeon pulled the blade out of the cavity and pressed the pedal and came to the same result, the window cut quickly for a moment, and then began to close extremely slowly.Another ultra mini blade was used to complete the case.They consulted with other team members after surgery and the consensus was that either the device may have gotten torqued too much or just locked up randomly.There was no patient injury.

Manufacturer Narrative

Evaluation summary one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the sluff chamber had score marks.The reported condition was confirmed.The investigation found the blade was not damaged.The blade did not move freely when activated in the forward/reverse mode.The sluff chamber was out of specification.The investigation identified the root cause of the reported event to be an assembly error.The provided lot number indicates that this product is an oem.Corrective action has been initiated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) received one truclear ultra mini tissue removal device opened by the account with the appropriate packaging in a undamaged condition.The product will expire on 2018¿02-03.The visual inspection of the returned product noted no visual abnormalities.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, as per the additional information received, the event occurred on (b)(6)2017.

• Brand Name: TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 6914865
• MDR Text Key: 88220748
• Report Number: 1643264-2017-21112
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 05/02/2018

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: 02/03/2018
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Device Lot Number: G22283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 10/18/2017; 04/04/2018
• Supplement Dates FDA Received: 11/16/2017; 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1