MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 33MM; STAPLE, IMPLANTABLE

Model Number	ECS33B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a low anterior resection procedure the device was fired.Tissue was on the thicker side, but tissue was easily compressed to below the midpoint on the tissue compression scale.Stapler was fired by the pa, who has fired the manual circular many, many times.No unusual sounds were heard.After firing, surgeon noticed that the staple line separated.He noticed no staples intact in either the proximal or distal segments of the tissue.The knife had been deployed because there was a clean cut of both proximal and distal sections of tissue.Further dissection was done to reattempt the anastomosis.When a second ecs33b was fired, the pa shared that she tried to fire the device but was unable to complete the squeezing of the handle completely.The surgeon then went "below" to complete the firing.Similar to the first firing, there appeared to be no deployed staples with a cutting of the tissue.Surgeon said that there were two completely circumferential donuts, with not visible staples engaged in the donuts.The surgery was delayed by sixty minutes.A handsewn anastomosis was done, and a temporary diverting ileostomy.The procedure was completed, but only after the patient was given a temporary diverting ileostomy.Post operatively, to attempt to diagnose the stapler issue the surgeon used a new ecs33b to fire into a green towel, to examine staple formation.The surgeon examined malformed staples and feels that there is a deficiency in the lot of staplers.The towel and pictures of malformed staples are available to submit with this report.There were patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.(b)(4).Per photographic evaluation: this is an analysis of a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a loose staple not properly formed.Based on the photo the event described photo confirmed, however, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device lot v95r5p, and no non-conformances were identified.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 were the indications for surgery? what surgical procedure was performed? did the patient receive any preoperative chemotherapy or radiation? were there any issues experienced with the device in the initial surgical procedure? what healthcare professional fired the device and what is his/her experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? was the device difficult to close? was the device difficult to fire? how many counter-clockwise revolutions of the adjusting knob were used to open the device? did the healthcare professional receive audible & tactile feedback when firing the device? were the donuts inspected? if so, please describe.Was a complete transection of the white breakaway washer visually confirmed? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.Was a leak test performed? if so, what type and what was the result? was the staple line visualized endoscopically during the initial surgical procedure? if a leak was confirmed what was observed at the site of the leak? how was the leak addressed? what is the current status of the patient? 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 field as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/02/2023.Additional information was requested and the following was received: i have not been able to get any additional answers from the surgeon.
Additional Manufacturer Narrative
(b)(4).Date sent: 01/10/2023.D4: batch # 492a75.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 ecs33b device arrived with no apparent damage.The breakaway washer was present, cut and there were 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.The event described could not be confirmed as no malformed staples were observed and the device performed without any difficulties noted.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.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: the firing stroke must be completed.Do not partially fire the instrument.Incomplete firing can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.Ensure that the firing trigger is fully squeezed to ensure proper staple formation and cutting of tissue.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 492a75, and no non-conformances were identified.

• Brand Name: CIRCULAR MECH XL SEAL 33MM
• 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: 15986585
• Report Number: 3005075853-2022-08654
• Device Sequence Number: 20355791
• Product Code: GDW
• UDI-Device Identifier: 10705036022947
• UDI-Public: 10705036022947
• 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,Followup
• Report Date (Section B): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: ECS33B
• Device Catalogue Number: ECS33B
• Device Lot Number: V95R5P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/27/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/10/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female