MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER; APPLIER, HEMOSTATIC CLIP

Catalog Number	EL314
Health Effect - Clinical Codes	Failure to Anastomose (1028); Peritonitis (2252); Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is 2017.Event day and event month were not provided.The lot/ batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information and device: were ethicon clips used with the el314 clip applier? what is the code of the clips that were used with the el314? what is the size of the clips used? was the lc800 based used to load the clips? was the el314 device inspected for proper alignment prior to use? is this specific el314 device available to send back for analysis? do you plan to inspect all el314 clip appliers at your facility to determine if any of these devices are worn so that any worn appliers can be removed from use? were there any clip formation issues noted during the initial procedure? how many clips were used on the patient side during the initial procedure? what was the location and shape of the detached clips that were found at reoperation? are there any photos available of clips found at reoperation? what was done in the reoperation procedure? how long was the patient hospitalized beyond their normal expected stay? what is the patient¿s current status? to date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that post-op, after a cholecystectomy procedure, using this type of forceps, el314, an incident involving a patient occurred in 2017 leading to a life-threatening complication, re-operation, and prolonged convalescence.In patient, the clips fell out resulting in bile draining into the abdominal cavity, peritonitis, and re-surgery during which the detached clips were observed.".

• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9322977
• Report Number: 3005075853-2019-23453
• Device Sequence Number: 2484415
• Product Code: HBT
• UDI-Device Identifier: 10705036003854
• UDI-Public: 10705036003854
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• 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): 10/17/2019

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: EL314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention