MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Model Number	ECS33A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5cg1x.Device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ecs33a device arrived with the anvil missing.Only casing half washer was present and there were no staples present.The device was reloaded with staples, a new washer was placed on the 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 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 reach on the cause of the reported event, the instructions for use do contain the following caution: open the instrument by turning the adjusting knob counter-clockwise.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 pull out while simultaneously rotating.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested, and the following was received: could you please provide more details for "stapler misfired"? the stapler was fired and a crunch was heard.After the 3/4 open turn the device, the device was unable to be removed.While pull back harder and the anastomosis was torn.A second circular stapler was fired and performed correctly with no issue.Doctor referenced that she thought the automatic purse stringer may have caused the issue.Did the device staple? yes.If the device stapled, was the staple line complete? the doctor believes so.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? the doctor didn't notice any malformed staples.Did the device cut? unknown.If the device cut, was the cut line complete? unknown.Were the cut line and staple lines equal? unknown.Was the device fired across a staple line? unknown.Please provide details as to how the reload did not work.N/a.Did the reload lock out and would not work? n/a.Did the reload begin to staple and cut, but then jammed? n/a.Did the device staple, but there was no cut line? unknown.If the device cut and stapled, were there any staples missing from the staple line? unknown.How was the procedure completed? second circular stapler was used and completed successfully.Could you please clarify if there were any patient consequences? no patient consequences after procedure was complete.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? no difference in post op care.Based on additional information received the first device was difficult to remove and the anastomosis was torn, and the second device worked as intended.Which device was difficult to remove and tore the anastomosis; ecs33a or ecs33b? ecs33a was the code in which the stapler tore the anastomosis according to the doctor.Just to clarify, was the removal issue and torn anastomosis referred to as the ¿misfire?¿ if no, what does misfire mean and what device is the misfire associated to; ecs33aor the ecs33b? are the devices available for return? the doctors called it that initially.Once more information was received, it was not a misfire on the stapler but wasn't able to be removed from the patient.The issue was associated with ecs33a.
Event or Problem Description
It was reported that during a colectomy the circular stapler misfired.Case was completed with another like device.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13154276
• Report Number: 3005075853-2022-00003
• Device Sequence Number: 17495825
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• PMA/510(K) Number: K940967
• 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
• Report Date (Section B): 01/04/2022

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 Expiration Date: 05/31/2026
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: U94M45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown