MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problems Use of Device Problem (1670); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was disposed of and will not be returned.Additional information received: the patient had a bowel movement prior to discharge from the hospital and passed the anvil prior to going home.The patient is aware and doing fine.

Event Description

It was reported that following a sigmoid colon resection procedure, the patient was at home and passed the anvil from the device used during the procedure performed on (b)(6) 2015.During the procedure, after firing the device, the surgeon reported opening the device four full turns, but then corrected himself to say four half turns.The surgeon did not know he left the anvil in the patient.He was moving quickly and didn't realize the anvil was missing.The surgeon could not see the anvil with a proctoscope.The surgeon pumped air into the rectum and still could not see the anvil.When pumping air into the rectum, no leak was detected.The surgeon did check the donuts in the stapler, but didn't realize the anvil was missing.There were no additional consequences reported for the patient and the patient is currently doing okay.The device has been discarded.The anvil is with the customer, but the customer will not release.

Manufacturer Narrative

(b)(4).Additional information: upon receipt and review of additional information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event; mdr decision has been re-run and revised to not reportable.

• Brand Name: ILS 33MM CURVED
• 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: 5025888
• MDR Text Key: 23886496
• Report Number: 3005075853-2015-05278
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2019
• Device Catalogue Number: CDH33A
• Device Lot Number: L4EC5E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2014
• 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