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

Model Number 72204064

Device Problems Break (1069); Detachment Of Device Component (1104); Overheating of Device (1437)

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

Event Date 04/27/2017

Event Type  malfunction  

Event Description

According to the reporter: occurred during a procedure.The bottom of the blade broke off in the hand causing the hand piece to become very warm.There was patient involvement but there was no patient injury.There was no medical intervention required.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: one device sample 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 blade was broken.The sluff chamber has score marks.The reported condition was confirmed.The investigation found the blade was broken.The blade seized up when activated in the forward/reverse mode.The sluff chamber outer dimension was out of specification.The investigation identified the root cause of the reported event to be an assembly error.Corrective action has been initiated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder,co, CT 80301 ; 2034925563
• MDR Report Key: 6582732
• MDR Text Key: 75688773
• Report Number: 1643264-2017-21034
• Device Sequence Number: 1
• Product Code: HIH
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2018
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• 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