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

Model Number 72204064

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during the hysteroscopy polypectomy / myomectomy, while the reported device was being used on the resection of tissue; the inner cylinder of the blade broke and lodged into the distal outer cylinder of the device causing shards of metal from the device to disperse throughout the patient's uterine cavity.It was unable to remove all amounts of metal from the patient but did remove the majority.This led to extended or time for 45 minutes and additional tools were needed to try and intervene to remove the metal shards.X-ray was not performed to locate the component or pieces.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the blade was broken and a small piece was missing.The reported condition was confirmed.The investigation found the blade was broken.The damage is indicative of forcing a bend that gets the inner tube out of alignment with the outer tube.The investigation identified the root cause of the reported event to be an assembly error.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the hysteroscopy polypectomy / myomectomy, while the reported device was being used on the resection of tissue; the inner cylinder of the blade broke and lodged into the distal outer cylinder of the device causing shards of metal from the device to disperse throughout the patient's uterine cavity.It was unable to remove all amounts of metal from the patient,but did remove the majority.This led to extended or time for 45 minutes and additional tools were needed to try and intervene to remove the metal shards.X-ray was not performed to locate the component or pieces.Pathology came back containing no metal as well.Surgeon described remnants of metal left in patient as ¿microscopic¿.The lot numbers provided in the photos.

• 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 city OK 73107
• MDR Report Key: 8482674
• MDR Text Key: 140904684
• Report Number: 1643264-2019-20005
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (y/n): N
• PMA/PMN Number: K161763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Device Lot Number: 4486969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other