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

Model Number ER420

Device Problem Leak/Splash (1354)

Patient Problem Hematoma (1884)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information was requested, and the following was obtained: please confirm if anastomotic leak or bleeding.What color cartridges were used throughout creation of sleeve? does the surgeon routinely wait 15 seconds prior to firing? does the surgeon pulse fire or use one continuous firing stroke? were there any difficulties during initial procedure to include staple formation? how was the post-op hematoma and leak identified? what was the location of both? what was done to address issues? what is the current patient status? the only other thing i can add is that it was a hematoma and the patient was transferred to another facility 2 weeks after the surgery.

Event Description

It was reported that post-operative by two weeks after a gastric sleeve the patient developed a leak which led to a hematoma.The surgeon did not apply any reinforcement to the staple line during the initial procedure.There is no additional information.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10298712
• MDR Text Key: 200830627
• Report Number: 3005075853-2020-03677
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• 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