MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 25MM; STAPLE, IMPLANTABLE

Model Number	ECS25B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch#: x95r49.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot/batch.Additional information provided: according to the surgeon he did a lap sigmoid colectomy.Stapler closed properly, dialed into green.It was fired.There were no staples on either end of the colon.Bowel had holes but were nor connected at all.No fired staples, no open staples.Inside the stapler there were good donuts no staples.Looked like staples were not loaded into it or didn't get pushed into anvil when it was fired.Additional information was requested, and the following was obtained: is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).Answer: the patient and family were informed, new anastomosis, no complications so far.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.
Event or Problem Description
It was reported that during a sigmoid colectomy that the doctor had a stapler misfire.The device cut but there weren¿t any staples at all in the device.Unknown of any patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/03/2023.D4: batch # 946a04.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 ecs25b device arrived with no apparent damage and no anvil was received.The breakaway washer was not present and there were no staples present, indicating that the device achieved a full firing stroke.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.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: firing the device with an unsecured anvil will result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.While closing the device, keep the organ segments in proper orientation.Inspect to ensure extraneous tissue is excluded.To close the device, turn the adjusting knob clockwise.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number 946a04, and no non-conformances were identified.

• Brand Name: CIRCULAR MECH XL SEAL 25MM
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 16132783
• Report Number: 3005075853-2023-00213
• Device Sequence Number: 3213137
• Product Code: GDW
• UDI-Device Identifier: 10705036022923
• UDI-Public: 10705036022923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: ECS25B
• Device Catalogue Number: ECS25B
• Device Lot Number: X95R49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown