ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
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Model Number NSLX137C |
Device Problems
Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch #: unknown.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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.
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Event Description
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It was reported that, during total laparoscopic hysterectomy, the jaws didn¿t open at all during vaginal incision.The jaws opened when the device was taken out from patient and adjusting the lever.When energizing, the device was functioned but there was a difficulty in cutting.It was also found that the jaws were misaligned when checking the tip of device.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4).Date sent: 2/14/2023.D4 batch #: v9611g.This is an analysis of an image submitted for evaluation.Image: the image provided by the customer shows an enseal device with the distal guide of the shaft damaged.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was returned with the distal guide weld broken.The device was connected to the generator and it was recognized.However, during the functional test, the knife could not be fired.Upon visual inspection of the device, it was observed that the knife was bent.The damage to the distal guide was not enough to prevent the jaws to open and close as expected.Due to the device returned condition we were unable to investigate further a manufacturing record evaluation was performed for the finished device batch v9611g , and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Please refer to the ifu for proper handling of the device, note that ¿caution: do not grasp tissue beyond the electrode surface, in the hinge of the jaws.Do not overfill the jaws of the instrument with tissue.This could result in difficulty opening the jaws, partially cutting tissue, and unintended injury.
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Search Alerts/Recalls
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