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

Model Number ER320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported that during a gastric bypass ("y-bypass") surgery, the patient had reported a pain.The surgery team discovered a fistula on the staple line with the development of an abscess.A surgery revision was performed.A blue test was performed and showed a leak.The abscess was drained and the fistula sutured.

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Date sent: 12/16/2021.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: was a leak test performed? if so, what type and what was the result? yes, a blue test and it was negative.Was the staple line visualized endoscopically during the initial surgical procedure? yes, inspection of the staple line and installation of additional clips to control bleeding.How many days postoperative did the leak occur? unk.How was the leak identified? scanner.What was observed at the site of the leak upon re-operation? abscess with collection.How was the leak addressed? cleaning, drainage and suturing.

• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12816674
• MDR Text Key: 280824627
• Report Number: 3005075853-2021-06946
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: 391A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention