MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LAPRA-TY* APPLIER - 33CM

Catalog Number	KA200
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.Additional information: the leak occurred from the anastomosis site.The size of monocryl was 3-0 and the size of needle was ur-6.Dr.Commented whether the cause of the leak was lapraty or not was not known.The hospital stay is prolonged.Additional information was requested and the following was obtained: "how many clips were used to complete the anastomosis? no information.Is the surgeon aware that the clips are only indicated to be used with braided vicryl suture? after this event, the sales rep explained the surgeon that the clips are only indicated to be used with braided vicryl suture.The sales rep reported additional information: the leak occurred from the anastomosis site.".
Event or Problem Description
It was reported that during a laparoscopic robot-assisted total prostatectomy, the placed clip slid during suturing after fixed on the monocryl.The device was used on the anastomosed site between the urethra and the bladder.The hospitalization was prolonged since leakage occurred.No blood transfusion was required.Another device was used to complete the case.

• Common Device Name: LAPRA-TY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7575150
• Report Number: 3005075853-2018-10405
• Device Sequence Number: 19257074
• Product Code: GDO
• UDI-Device Identifier: 20705036012648
• UDI-Public: 20705036012648
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: KA200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1