|
Model Number M650G |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/22/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that a patient underwent a thoracoscopy procedure on (b)(6) 2022 and suture was used.The suture pulled off of the needle during the surgery.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
|
|
Manufacturer Narrative
|
Product complaint # pc- (b)(4).Component code: (b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: were the needles removed from the patient? removed.Was there any adverse patient outcome? none.Lot number? rebckk.Event related to mw # 2210968-2022-03735, mw # 2210968-2022-03736, mw # 2210968-2022-03737, mw # 2210968-2022-03739, mw # 2210968-2022-03740.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Date sent to the fda: 06/14/2022 h6 component code: g07002 - device not returned this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Photo analysis: the product was not returned for evaluation.A visual inspection of the received images were performed.Visual analysis of the image received determined that an open product box and six detached needles can be observed.Product code m650g, the image is not clear to determine the failure mode.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Additional information: h3 evaluation: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.One open box with (b)(4) unopened samples of product code was received in order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.A functional test was performed, and the pull force result was above the minimum requirements.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|