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

Catalog Number ERXXX

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Email received from hospital: "i spoke to the surgeon, the clip wasn t loading properly and cut the vessels ,we have change it 3 times i, the same problem arise." in response to this additional information provided, attempts have been made to obtain the following information: did only one device have this issue or did more than one device have this same issue during this procedure (as in the additional information, you stated "i spoke to the surgeon, the clip wasn t loading properly and cut the vessels, we have change it 3 times i, the same problem arise")? if more than one device had this same issue during procedure, how many devices were of issue during this procedure? in response to this request for additional information, the following additional information was received: email from sales rep: "no further additional information available.".

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2019.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: please clarify the event: did the clip cut the vessel? or did the jaws cut the vessel? did the clip feed sideways, slowly, or not feed at all in the jaws of the device? did the clip drop or eject from the jaws of the device? did multiple clips feed into the jaws of the device at the same time? 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 Description

Lt was reported that during an unknown procedure, the ligaclips weren¿t loading properly and therefore when they tried to clip the vessel, it cut through instead of sealing.They said there was no extra harm to the patient but they had to keep trying until the clips were in properly.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9492930
• MDR Text Key: 189942134
• Report Number: 3005075853-2019-24562
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ERXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1