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 Hematoma (1884)

Event Date 03/02/2022

Event Type  Injury  

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.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.(b)(4).Related events captured via 2210968-2022-08426.Citation: seo iy, oh th.Migration of lapra-ty clips in ureter and collecting system mimicking urinary stones following laparoscopic partial nephrectomy.J urol surg, 2022;9(3):209-211 https://doi.Org/10.4274/jus.Galenos.2022.2021.0124.

Event Description

Title: migration of lapra-ty clips in ureter and collecting system mimicking urinary stones following laparoscopic partial nephrectomy we present a rare case of the clip migration after laparoscopic partial nephrectomy(pn) in which the clips were misdiagnosed as urinary stones.A 57-years-old female presented with right flank pain 3 months after the surgery.A computed tomography scan showed a 4 mm stone in the left upper ureter and hydronephrosis.Another 3 mm stone was also detected in the left upper calyx.Rigid ureteroscopy and flexible ureterorenoscopy revealed two lapra-ty clips (ethicon endosurgery, cincinnati, oh, usa), which were embedded in the upper ureter and calyx.The clips were fragmented by holmium laser lithotripsy and removed with stone basket.Pain and hydronephrosis are resolved at follow-up.Intrarenal movement of lapra-ty clip after pn is very rare, but it is possible.As in our case, the migrated clips into the collecting system can obstruct the ureter and induce similar symptoms and ct findings of urinary stone.During pn, clear operative view should be ensured, and excessive tension to the suture knot should be avoided to prevent migration of the clip.

• 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: 15601829
• MDR Text Key: 301719582
• Report Number: 2210968-2022-08427
• 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,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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: 09/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female