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 Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Title: standardization of surgical outcome across the tumor complexity spectrum in robotic partial nephrectomy.This study aimed to analyze the benefit of a standardized approach to robotic partial nephrectomy on the reproducibility of outcomes across different tumor complexities.Between may 2014 and march 2022, 496 patients who have undergone a transperitoneal robotic-assisted partial nephrectomy for kidney cancer using the first assistant sparing technique were included in the study.There were 315 males and 181 females with a median age of 62 years and a median bmi of 27.77 kg/m2.All patients underwent first assistant sparing technique.For the initial renorrhaphy layer, a competitor 3-0 monofilament barbed suture was placed (manufacturer: covidien).For the second layer, 3 to 4 15 cm polyglycolic acid 0 vicryl sutures (ethicon) on a 37mm 1/2 curve needles were placed.For the polyglycolic acid sutures, competitor ligation clips (manufacturer: teleflex) and absorbable suture clips lapra-ty (ethicon) were loaded 1 cm from the tail of the sutures.These sutures were stabilized to the anterior abdominal wall.After the tumor was excised, the 3.0 barbed wire suture was used to suture the collecting system and the vessels.After running the suture, the competitor ligation clips were used to stabilize sutures.Renal artery was unclamped early then the second cortex layer was closed after early unclamping.The competitor ligation clips were used to stabilize these sutures as well.Once the renorrhaphy was completed, all needles and clamps were removed outside the body.Surgical drain was not routinely placed.Reported complications included unspecified postoperative complications (n=?), unspecified surgical complications (n=?) and unspecified major complications (n=?).In conclusion, irrespective of tumor complexity, approaching robotic partial nephrectomy using a standardized approach will offer patients favorable perioperative outcomes.This approach has standardized our preoperative counseling, patient expectation, and postoperative surgical pathway across the tumor complexity spectrum.

Manufacturer Narrative

(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.Attempts are being made to obtain 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? which specific ethicon products have been used during the procedures (product code, lot number)? 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? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: related events captured via 2210968-2023-07582 and 2210968-2023-07583.Citation: journal of laparoendoscopic & advanced surgical techniques; volume 33, number 2, 2023; https://doi.Org/10.1089/lap.2022.0275.

• 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 ; 9083863534
• MDR Report Key: 17903932
• MDR Text Key: 325268620
• Report Number: 2210968-2023-07583
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• 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: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 3-0 MONOFILAMENT BARBED SUTURE, COVIDIEN
• Patient Outcome(s): Required Intervention