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Model Number 174317 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Unintended Radiation Exposure (4565)
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Event Date 05/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopic hysterectomy, two grasping forceps had issues happened in the same patient.The first device unscrewed the jaws of the instrument, and the screw was not found.The team was unsure if it is in the cavity or outside patient's body.X-ray was done and no screw was found in the patient, while the lock lever of the second device broke and the piece jumped out of the surgical field.Another forcep was used to complete the case.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the jaws of the instrument were damaged.It was reported that a component disengaged from the device into the surgical cavity.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
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Manufacturer Narrative
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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.
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Event Description
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According to the reporter, during a laparoscopic hysterectomy, in the middle of the surgery, the surgeon detected that the first device's jaws (lot no.: p0k0368y) did not close and saw that the screw that held them was coming out.The surgeon tried to remove the instrument, as the jaws were open and did not close, it did not pass through the 5mm trocar, so they removed both the trocar and the forceps through the trocar incision.X-rays were taken in case the screw had fallen into the cavity but nothing was found.The locklever of the second device (lot no.: p0f0050y) broke and the piece jumped out of the surgical field.Another forcep was used to complete the case.
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Search Alerts/Recalls
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