MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE** ILS CIRCULAR STAPLERS; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As a lot/batch was not provided, a device history could not be performed.Date of event: month and day unknown.Only year (2017) is known.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What size stapler was used? where in the green gap scale was the indicator located prior to firing? did the surgeon wait 15 seconds and retighten prior to firing? at any time, did the healthcare professional observe any staple malformation issues? if so, please describe the shape of the staples.What is the current patient status?.

Event Description

It was reported that after a roux-en-y procedure the patient was readmitted for bleeding.The doctor reoperated on the patient and oversewed to control the bleeding.The patient has been released.No other information is known.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 6973077
• MDR Text Key: 90086660
• Report Number: 3005075853-2017-05621
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention