MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH STD 29MM; STAPLE, IMPLANTABLE

Catalog Number CDH29B

Device Problems Failure to Cut (2587); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Hold for rw 2.6 it was reported that during a laparoscopic sigmoidectomy, the device could not be removed from the patient after firing.Therefore, the incision was brought from the anus and removed with scissors.It was then anastomosed elsewhere with another device to complete the case.The surgeon said, ¿the sound of the washer cracking when firing was dull.In addition, the force required to fire was duller than usual.¿ there were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024.D4: batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.Additional information received: there were two rotations of the knob at the time of removing.At the time of firing, the staple-on-staple area on the left side of the patient was anastomosed poorly.(the knife did not cut through the tissue.) there was no change in the surgical technique.The patient's postoperative condition is good.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 3/8/2024.D4: batch #446c99.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the cdh29b device arrived with no apparent damage.The breakaway washer was present, cut and there was no staples present, indicating that the device achieved a full firing stroke.In addition, the washer and knife were noted to have nicks.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.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 meet the staple form release criteria.However, the washer cut was not a perfect circle and it was difficult to remove the test skin from the device due to knife damage.A photo was provided and it shows the device along with an anvil.The event reported was confirmed and it is related to improper use of the device.The damage on the knife and washer is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 446c99, and no non-conformances were identified.

• Brand Name: CIRCULAR MECH STD 29MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18642054
• MDR Text Key: 335814544
• Report Number: 3005075853-2024-01026
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH29B
• Device Lot Number: 446C99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1