MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Device Fell (4014)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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 the device: which vessel did the clip fall off of? how many clips were placed on the vessel? were there any device issues identified in the initial procedure? were there any device issues identified in the re-operation procedure? how was bleeding identified? were there any clip formation issues in the initial procedure? were there any clip formation issues in the re-operation procedure? please clarify: in the event, you reported the patient had a post-op complication and was brought back to the o.R., but on the complaint submission tool form, you answered no to the following question: ¿did the patient require revision surgery or hardware removal? ¿ no.¿ did the patient have re-operation for post-op complication of bleeding? did the patient have any other surgical procedure besides the initial lap chole procedure and re-operation procedure? to date no response has been provided and no device has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that post-op, after a laparoscopic cholecystectomy, the surgeon was called after patient had a post-op complication.Patient was brought back to o.R.For re-operation and surgeon realized the clip fell off and the belly was full of blood.Surgeon switched to an applied clip applier.The applied product scissored and surgeon asked for an er420.The patient recovered and has been discharged according to the surgeon.

• Type of Device: CLIP, IMPLANTABLE
• 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: 9263223
• MDR Text Key: 166796937
• Report Number: 3005075853-2019-23119
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• 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