It was reported that patient underwent an unknown procedure in (b)(6) 2024, and suture was used.It was reported that during the surgery, the suture was stuck which was difficult to dispense before using on patient during surgery.Also, the problem of pulling off suture needle had happened.Changed another one to complete surgery.There is no reported patient consequence.No additional information could be provided.
|
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.The following information was requested, but unavailable: -please confirm if the pull off occurred during dispensing before use on the patient or during use on the patient.Attempts are being 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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
|
Product complaint # (b)(4).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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned devices.The returned sample determined that it was received, one dispensed suture that pertained to product code vcp303h.During the visual inspection of the returned sample, the needle was not returned for evaluation.The suture was examined, and the ends of the suture were observed damaged.In addition, body fluids were found along of strand.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.As per the sample condition, no conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.H3 investigation summary:the product was returned for evaluation.Visual inspection was conducted on the returned devices.The returned sample determined that it was received, one dispensed suture and a detached needle that pertained to product code vcp303h.Upon visual inspection of the detached needle, the attachment condition was as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The suture piece inspected, and the insertion mark was observed to be as expected.In addition, the other extreme was noted to be cut, probably caused by a surgical instrument.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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.
|