MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Impairment (4499)

Event Date 04/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? (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 regarding the additional events.Events related to monocryl suture and the (b)(6) female captured via 2210968-2021-05162.Events related to vicryl suture and unspecified patients captured via 2210968-2021-05163.Events related to monocryl suture and unspecified patients captured via 2210968-2021-05164.Events related to monocryl suture and the (b)(6) male captured via 2210968-2021-05166.Events related to vicryl suture and the (b)(6) male captured via 2210968-2021-05167.Events related to lapra-ty and the (b)(6) male captured via 2210968-2021-05168.Events related to vicry suture and the (b)(6) female captured via 2210968-2021-05169.Events related to lapra-ty and the (b)(6) female captured via 2210968-2021-05170.Citation: international journal of urology /volume 27, issue 5 /p.457-462 first published: 16 april 2020 https://doi.Org/10.1111/iju.14224.

Event Description

Title: surgical details and renal function change after robot-assisted partial nephrectomy.The objectives of this study is to investigate whether di×erences in surgical details during robot-assisted partial nephrectomy impact postoperative renal function.A total of 751 patients who had received rapn between 2008 and 2016 were reviewed.Tumors were excised using cold scissors in the initial 450 (60%) patients.Cutting planes were mostly perpendicular to the cortical surface until suõcient depth was reached.In the latter 301 patients, after cortical incision was made using the scissors, the tumor was split-separated from the surrounding parenchyma using forceps until suõcient depth was reached and cutting was minimized.After complete tumor excision, hemostatic sutures and collecting system repair were carried out as required using absorbable 4-0 monoòlament continuous sutures (monocryl; ethicon,cornelia, ga, usa) in the initial 481 (64%) patients.In the latter 270 patients, titanium clips were applied when vessels were encountered during splitting and vessels were cut.Additional suture was carried out only when collecting system repair was required.In 330 (44%) patients, renorrhaphy was carried out with continuous running suture using 2-0polymer absorbables (vicryl; ethicon).In the remaining patients, two-layered interrupted suturesimilar to vertical mattress was made by a modiòed janetschek method.First, simple mattress to the bottom of the defect was carried out to close dead space.Then using the same suture, more superòcial, overrunning mattress to approximate the cortical surfaces for coaptation was made.Hem-o-lok (weck closure systems, research triangle park, nc, usa) and lapra-ty (ethicon endo-surgery, cincinnati, oh, usa) were used in the place of knots.Reported complications included the gfr of the entire cohort decreased by a median of 9.8 ml/min/1.73 m (22%) at postoperative 3 months,nephrometry,renal function decline at 3 months postoperatively, larger parenchymal volume loss.A (b)(6) man without any medical comorbidities.His preoperative kidney volume was 150.9 mm, and his gfr was36.4 ml/min/1.73 m.A (b)(6) woman with hypertension.Her preoperative kidney volume was 142.7 mm, and her gfr was 48.5 ml/min/1.73 m.In conclusion hemostatic sutures during robot-assisted partial nephrectomy might interfere with long-term renal function recovery irrespective of parameters that determine the initial function change.As the splitting method reduces the use of sutures, modifying these details might help preserve renal function.

• Brand Name: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11920836
• MDR Text Key: 267053783
• Report Number: 2210968-2021-05165
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1