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

Catalog Number	ECS29B
Medical Device Problem Codes	Failure to Fire (2610); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/14/2024 d4 batch # unk b3: only event year known: 2024 d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? were there staples missing from the staple line? could you please clarify how long was the delay (hours/minutes)? could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 colon resection they had some issue in removing the stapler ( after clips shooting and tip opening).The mucosa remained stuck in the stapler and in some area the anastomosis remained open.The surgery has been ended applying a manual anastomosis as reinforcement.There was a surgical delay in the procedure the exact time is unk.The procedure was successfully completed.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/5/2024.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/17/2024.Additional information was requested, and the following was obtained: was there any other issue on the ecs29b? the facility regularly uses the instrument and, according to the surgeon, has been used following all of our guidelines.The instruments did not present any additional problems compared to those already described, the difficulties were manifested only during extraction.When retracting the instrument, the tension exerted compromised a few points, requiring an oversight which caused a delay in the procedure.

• Brand Name: CIRCULAR MECH XL SEAL 29MM
• 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: 19981142
• Report Number: 3005075853-2024-05957
• Device Sequence Number: 8141516
• Product Code: GDW
• UDI-Device Identifier: 10705036022930
• UDI-Public: (01)10705036022930(17)281231(10)C9DA2A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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 Catalogue Number: ECS29B
• Device Lot Number: C9DA2A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/10/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/05/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown