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

Catalog Number KA200

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problems Fever (1858); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Information received: the leak occurred from the anastomosis site.The size of monocryl was 3-0 and the size of needle was ur-6.The patient has a fever of 39 c and the infection was suspected.Ct scan will be performed.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 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 and the catheter could not be removed.No blood transfusion was required.

Manufacturer Narrative

(b)(4).Device analysis: the analysis results found that the ka200 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended over suture.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed and "certed" by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing.

• Type of Device: LAPRA-TY APPLIER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7590905
• MDR Text Key: 110746573
• Report Number: 3005075853-2018-10531
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036012648
• UDI-Public: 20705036012648
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KA200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1