MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72205001

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a hysteroscopy with myomectomy, the case went smoothly but they noticed the unit alerted the room that the fluid deficit had jumped from 140 ml to 270 ml to 1000 ml fluid deficit.The measurement was not accurate as no one touched the unit, the physician completed the procedure and no perforation occurred.They completed a manual count of the fluid and concluded the procedure fluid deficit was 140 ml.They performed a scales per the instructions for use(ifu) on the control unti 72205000, and it the screen should read: value fluid bags: 0g value cannister: 0g the scales test was performed: value fluid bags: 5g - 9g ranged value cannister: -250 to -268g ranged there was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found there were no visible indications of transport damage or misuse.The reported condition was confirmed.The investigation found the device failed due to a shift in calibration.The investigation identified the cause of the reported event to be a calibration issue.The condition of the product was addressed by a calibration.A review of the risk file confirmed the failure mode, occurrence, hazard and overall risk category was addressed adequately.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: after review of the tracking number provided by the common carrier¿s recorders indicate that the sample has been delivered to the oem/cm but no repair information was available.The reported condition was not confirmed due to insufficient information provided.No analysis information has been received to date, if the repair information is received we will reopen and amend this complaint.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

2020-10-01, 22:47:49, saclas2: reported in error as medtronic is not the legal manufacturer.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.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.

• Brand Name: HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8938394
• MDR Text Key: 155807519
• Report Number: 1717344-2019-01110
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K180496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: 72205001
• Device Catalogue Number: 72205001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 02/03/2020; 04/06/2020; 09/30/2020
• Supplement Dates FDA Received: 02/28/2020; 04/20/2020; 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1