MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH25A

Device Problems Failure to Form Staple (2579); Torn Material (3024)

Patient Problem Nicks, cuts or tears of dura or other tissues by device (1417)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that during an open esophagectomy, the firing force was higher than expected.The device was used for esophagogastroanastomosis.However, the doctor felt that something was wrong when the device intended to be removed.Then, it was found that the anvil side of the anastomosis site was tore.The surgeon checked this anastomosis; it was found the staple was unformed.Eventually, the edge of the staple line was recut and this anastomosis was performed by hand suture.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).At the time of this submission, the device has not been returned for analysis.If the device is received at a later date, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Additional information: photographic analysis: based on the photo evidence of the subject cdh25a, the root cause of the complication was due to the tissue being unevenly loaded within the device during the firing.The analysis results found that the cdh25a device arrived with the anvil missing, otherwise in good visual condition.As the original anvil was not received, further investigation with the original anvil could not be performed.The breakaway washer was not present and the device was received fully loaded with staples, which indicates that the device was not used.It is possible that the returned device is not the one used in the procedure.In addition pictures provided were review during analysis, the pictures showed that the device was not in firing range causing the staples to not properly form.A new washer was placed on the returned device and it was tested for functionality with a test anvil; it fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples were noted to have the proper b-formed shape.It should be noted that when removing the device; open the instrument by turning the adjusting knob counterclockwise.For easy removal, only open the instrument one-half to three-fourths revolutions.To assure the anvil is free from tissue, rotate the instrument 90° in both directions.To withdraw the open instrument, gently apply rearward traction while simultaneously rotating.Please reference instructions for use for additional information needed.The device history records were reviewed and the manufacturing criteria was met prior to the release of the device.

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the cdh25a anvil was received for analysis without a device.The anvil was received with the breakaway washer present.The washer was cut and only the anvil half was returned.The anvil was place on the test device and removed without any difficulties noted.No lot or batch were provided, a batch history record review could not be performed.

• Brand Name: ILS 25MM CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4330195
• MDR Text Key: 5211633
• Report Number: 3005075853-2014-08663
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983536
• 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,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2019
• Device Catalogue Number: CDH25A
• Device Lot Number: L4F14U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2015; 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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