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 Problems Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 vicryl suture captured via 2210968-2021-04975.Citation: serra-aracil et al.Mini-invasive surg 2019;3:37.Doi: 10.20517/2574-1225.2019.36.

Event Description

Title: management of the main postoperative surgical complications after transanal endoscopic microsurgery: an observational study.This observational study aimed to describe the frequency of occurrence of postoperative surgical complications after tem according to their cl-d (clavien-dindo) classification and to describe the therapeutic management protocol in the most frequent complications.All patients were operated on by surgeons at the parc tauli university hospital, coloproctology unit from june 2004 to june 2019.A total of 716 (n=430 male; n=286 female) patients with median age of 71 years old were included.Median lesion size was 4 cm.Neoadjuvant treatment was administered in 44 (6.1%) patients.Median distance from the lower edge of the lesion to the anal verge was 7 cm, and from the upper edge to the anal verge was 11 cm.The most frequent location was the lateral quadrant, reported in 318 (44.4%) patients.Sessile morphology was the most common in 329 (47.1%) patients.All patients with indication of tem underwent a preoperative study protocol incorporating endorectal ultrasound (us) and rectal magnetic resonance imaging (mri).These examinations classify the patients into five groups of preoperative indication: group i with curative intention (benign tumors), which, after us and mri, are staged us-mri,t0-1 and us-mri,n0; group ii, with curative intent (low grade adenocarcinomas, us-mri,t0-1 and us-mri,n0); group iii, consensus indication (low grade adenocarcinomas, us-mri,t2 and us-mri,n0) who reject radical surgery; group iv, palliative care; and group v, atypical indication.Inclusion criteria were patients in preoperative indication groups i-iv who were candidates for tem surgery.The techniques used for local rectal excision are either tem (richard wolf, knittlingen, germany) or teo (karl storz gmbh, tüttlingen, germany).The lesion¿s defect on the rectal wall should be sutured to prevent complications due to stenosis of the rectal lumen (in large defects) and postoperative bleeding due to fecal erosions.A long-lasting 3-0 absorbable monofilament suture such as polydioxanone (pds, monoplus) is used with a 20-22 gauge curved cylindrical atraumatic needle.A 10 cm length is cut to facilitate handling in the interior of the rectoscope.A vicryl (ethicon) clip is placed at the ends, using an instrument known as lapra-ty for placement, as an anchor and to avoid knot tying.A curved needle holder is used, which facilitates handling the suture.Reported complications included rectal bleeding cl-d grade i (n=85), clavien-dindo grade ii morbidity (n=5 ), clavien-dindo grade iiia morbidity (n=10), clavien-dindo grade iiib (n=11), clavien-dindo grade iva (n=4), clinically relevant complication (cl-d = ii) (n=25), urinary complications (n=30), urine infections (uti) (n=9), acute urine retention (n=20), hematuria and traumatic urine catheter insertion (n=5), infectious complications (n=14), pelvic or perianal abscess (n=7) and were treated by antibiotics and local debridement, except in two cases that required colostomy, pneumoperitoneum/retropneumoperitoneum/pneumomediastinum (n=2) and recto-vaginal fistula (n=5).Two patients underwent exploratory laparotomy, one for severe pneumoperitoneum on chest x-ray and the other due to massive neuro-retroperitoneum on abdominal ct.In conclusion, clinically relevant complications after tem are rare occurrences.Nonetheless, a protocol for their management needs to be established to ensure that their importance is not underestimated, and to avoid unnecessary or excessively aggressive treatments.

• 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: 11880932
• MDR Text Key: 266082289
• Report Number: 2210968-2021-04976
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: 05/11/2021
• 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
• Patient Outcome(s): Required Intervention