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); Incontinence (1928); Perforation (2001); Hernia (2240); Hematuria (2558); Unspecified Tissue Injury (4559)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint (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 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 author/surgeon believe that ethicon products (vicryl suture and lapra-ty absorbable suture clip ) involved caused and/or contributed to intra-operative complications (uretral/rectal injuries and perforation of the small intestine).Does the author/surgeon believe that ethicon products (vicryl suture and lapra-ty absorbable suture clip) involved caused and/or contributed to postoperative complications (three cases of rupture of the suture at the urethrovesical anastomosis site, lymphatic fistula, subcutaneous abscess, pelvic abscess, hematuria, inguinal hernia, urethral stenosis, urethrorectal fistula, urethral lithiasis and sui) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (vicryl suture and lapra-ty absorbable suture clip) used in this procedure/study? please specify.If yes, please provide patient demographics for the patients that experienced the intra-operative and post-operative complications and details of events if available.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Was any surgical intervention was performed for rupture of the suture (suture breakage) at the urethra-vesical anastomosis site? please specify what suture product broke at the urethra-vesical anastomosis site? citations:kawasaki medical journal 46:1-8,2020 doi:10.11482/kmj-e202046001.Note: malfunction events were submitted via 2210968-2021-04788 and 2210968-2021-04789.Adverse events were submitted via 2210968-2021-04786.

Event Description

Title: treatment outcomes of laparoscopic radical prostatectomy at (b)(6) hospital.This study was conducted in 196 patients who were diagnosed with localized prostate cancer and underwent lrp between december 2009 and november 2017.The median patient age was 69 years (range, 56- 79 years), median body mass index was 23.3 kg/ m2 (range, 15.2-33.2 kg/m2), and median prostatespecific antigen (psa) level at diagnosis was 7.4 ng/ ml (range, 2.2-42.0 ng/ml).As for clinical stage, t1c accounted for 63 cases, t2a 43 cases, t2b 31 cases, t2c 57 cases, t3a 1 case, and t3b 1 case.Gleason score at biopsy was = 6 in 42 cases, 7 in 135, and = 8 in 19.The median prostate volume was 22 ml (range, 7.3-65.6 ml).The surgical procedure was as follows: first, bilateral obturator lymphadenectomy was carried out.Then, an incision was made in the endopelvic fascia and the lateral surface of the prostate was detached while preserving the puboprostatic ligament.The dorsal vein complex was ligated using 2-0 vicryl sutures and the area between the bladder and prostate was resected while making sure that the internal urethral orifice was preserved.Then, the vas deferens and seminal vesicle were detached and exposed, ligated using 3-0 vicryl sutures (ethicon), and removed from the body using an endoclose device.Denonvilliers¿ musculofascial plate was carried out using 3-0 vicryl sutures, and urethrovesical anastomosis was performed by placing a running suture starting at 3 o'clock and turning clockwise using 3-0 monofilament absorbable sutures and a lapra-ty absorbable suture clip (ethicon).A 20-fr indwelling urethral catheter was placed and bladder irrigation was performed.Verifications were made to confirm that there was no leakage, and then the stump of the dorsal vein complex on the bladder side was ligated to the puboprostatic ligament using 3-0 vicryl sutures(ethicon) (anterior suspension).Finally, an indwelling drainage tube was placed and the operation was complete.Early postoperative complications included rupture of the suture at the urethrovesical anastomosis site (n=3), lymphatic fistula (n=3), subcutaneous abscess (n=1), pelvic abscess (n=1), hematuria requiring blood transfusion (n=1), inguinal hernia (n=28), urethral stenosis (n=8), urethrorectal fistula (n=1), urethral lithiasis (n=1) and sui.Intraoperative complications included uretral injury(n=1), rectal injury (n=7), perforation of the small intestine (n=1).In conclusion, the oncological outcomes were similar to that reported by previous reports, but postoperative stress urinary incontinence and complications were slightly worse.In the future, further improvement of the surgical technique was desired.In conclusion, lrpn is associated with a significantly shorter ot compared to ltpn for posterior ct1 rms.Both surgical approaches are safe, feasible and credible, demonstrating optimal results.

• 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: 11853070
• MDR Text Key: 265649385
• Report Number: 2210968-2021-04787
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 05/10/2021
• 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