MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problems Sticking (1597); Physical Resistance (2578); Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.(b)(4).Additional information received from call with surgeon: after mobilization, the device was used on the base of the appendix.It was stated that the device was difficult to close.The surgeon fired the device but it did not fire properly.Unclosed staples were noticed in the abdomen and partially closed staples were on the appendix.It took multiple attempts to open the device and the handles were eventually pulled apart.It was noticed that the base of the cecum was open.It was also mentioned that there was more resistance to fire the device and it cracked a little.The patient was an adult with acute appendicitis and inflamed tissue.

Event Description

It was reported that during a laparoscopic appendectomy procedure the device was stuck on the appendix stump after the first firing which fired malformed and unformed staples.The surgeon struggled to open the jaws and the jaws did eventually open, but it was unknown how.This resulted in the cecum tearing and the surgeon had to convert to open to repair it by suturing.No buttressing material was being used.It was unknown which reload was being used.No additional product of the same product code was opened to complete the procedure.After the procedure, the surgeon opened and dry-fired an additional like device and felt that there was too much resistance in the firing.The complications resulted in the patient having to stay longer in the hospital.

Manufacturer Narrative

(b)(4).Batch # p55173.The device was visually inspected and no obvious issues were identified with the device.The device was opened and closed several times without difficulty.The device was test fired with a replacement cartridge and produced a complete staple line with no cutting or staple formation issues observed.The cartridge was visually inspected and there was damage to the cartridge indicating that the knife was pushed out of the knife slot and into the body of the cartridge.The knife appeared to cut into some of the drivers as well.The difficulty opening the device was like caused by the knife being stuck in the cartridge body.What may have caused the knife to become diverted into the cartridge body is not known.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6672776
• MDR Text Key: 78560451
• Report Number: 3005075853-2017-03266
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: ATS45
• Device Lot Number: P4R12W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention