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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Incontinence (1928); Obstruction/Occlusion (2422)
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Event Date 09/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.1.Does the author/surgeon believe that ethicon products (vicryl suture, vicryl rapide suture, pds suture, monocryl suture) involved caused and/or contributed to post-op complications (clavien dindo i, ii, iiia and iiib, urine leakage, not sufficient erectile funtion, blood loss, required re-operations and bladder contracture) described in the article? please specify.2.Does the author/surgeon believe there was any deficiency with the ethicon products (vicryl suture, vicryl rapide suture, pds suture, monocryl suture) used in this study? if yes, please describe.3.If yes, please provide patient demographics for the patients that experienced the post-operative complications (clavien dindo i, ii, iiia and iiib, urine leakage, not sufficient erectile funtion, blood loss, required re-operations and bladder contracture)? 4.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: https://doi.Org/10.12669/pjms.37.1.2719.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-09805, 2210968-2021-09807 and 2210968-2021-09809.
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Event Description
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Title: comparison of robotic and open radical prostatectomy: initial experience of a single surgeon this study aimed to make a comprehensive comparison of the first hundred robot-assisted radical prostatectomy (rarp) and open retropubic radical prostatectomy (rrp) cases of a single surgeon in a high-volume center.A total of 200 patients (n=100 rarp ; n=100 rrp) who met the inclusion criteria were analyzed.In the robot-assisted radical prostatectomy: all robotic surgeries were performed with da vinci® robotic surgical systems (intuitive surgical).Surgical interventions with the robotic technique were performed with the posterior approach.Under intratracheal general anesthesia, the patient was placed in the maximum trendelenburg position and an 18 fr urethral catheter was introduced.Skin and subcutaneous incision was made at the level of 2 cm superior to the umbilicus.Veress® needle was entered into the abdominal cavity from this area, co2 insufflation was started.12 fr camera port, other robot ports and assistant port were entered.Following this, docking was done.In the posterior approach, the vas deferens and seminal vesicles are dissected before the retzius space is created.A u-shaped incision was made in the peritoneum 1-1.5 cm above the rectum over the vas deferens.The areolar tissue in the region was dissected in order to locate and dissect the vas deferens.The endopelvic fascia is incised and opened.Finally, the resulting levator ani fibers were removed.Right and left puboprostatic ligaments were cut.The dorsal venous complex was passed with 40 mm 0 vicryl® stitches and knotted.Then, an incision was made with the monopolar scissors to separate the bladder and the prostate floor.Then, the incision was made through the bladder-prostate border and the bladder neck was cut.The catheter was removed and the posterior urethra was cut.The surgical specimen was then removed and placed into a laparoscopy bag or left in the pelvis.Then the endopelvic fascia was opened, the venous plexus was ligated with 0 vicryl® and cut.The urethra was released, suspended and cut.The prostate was released from denonvilier fascia with sharp and blunt dissections.Bilateral ductus deferens were clamped and cut, the right seminal vesicle, left seminal vesicle, along with the prostate, were removed, and the bladder neck was narrowed with a 2/0 vicryl rapid® suture.A 22 fr foley catheter was introduced.Urethrovesical anostomosis was created in six quadrants with 2/0 monocryl® suture.One drain was placed on the operation site, fasia was closed with 0 pds®, subcutaneous tissue was closed with 2/0 vicryl rapid®, and the skin was closed with 2/0 silk suture.While the operation time was in favor of the open group (117 vs 188 min, p<0.001), the estimated blood loss (328 vs 150 ml, p<0.001), blood transfusion rate (12 vs 2, p=0.021), and re-operation rate (6 vs 0, p=0.001) were in favor of the robotic group.Mean length of hospital stay (5.4 vs 3.1, p<0.001), urine leak rate (11 vs 2, p=0.033), complication rate (37 vs 16, p=0.018), and the 12th month continence rate (67 vs 85, p=0.002) were better in the robotic group.Reported complications included n=18 clavien dindo i, n=19 clavien dindo ii, n=13 clavien dindo iiia, n=3 clavien dindo iiib, n=13 urine leakage, n=86 not sufficient erectile function, n=? blood loss, n=6 requires re-operation and n=8 bladder contracture.
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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary :as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.Device history lot : null.Device history batch : null.Device history review :null product complaint # (b)(4).Date sent to the fda: 02/04/2022.Corrected information: h6.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.
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Search Alerts/Recalls
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