MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, STRAIGHT; STAPLE, IMPLANTABLE

Model Number	SDH25A
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: r5877m.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the emergency gastric surgery surgery, could not fire when severing gastrointestinal tissue.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/30/2020.F10; h6: component code = others (g07).Device analysis: the analysis results found that the sdh25a device arrived with no apparent damage.The breakaway washer was present and uncut, the device was fully loaded with staples, indicating that the device had not being fired.The device was tested for functionality with the returned washer and 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.Although there is no direct evidence of use error, the instructions for use do contain the following caution: if excessive force is required to close the device, this may indicate there is too much tissue or thickened tissue in the device.Attempting to fire the instrument in this condition may result in poor staple line integrity with possible leakage or disruption.In addition, instrument damage or failure may result.The event described could not be confirmed as the device performed without any difficulties.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: ILS 25MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10837136
• Report Number: 3005075853-2020-05985
• Device Sequence Number: 3500913
• Product Code: GDW
• UDI-Device Identifier: 10705036003526
• UDI-Public: 10705036003526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 03/19/2023
• Device Model Number: SDH25A
• Device Catalogue Number: SDH25A
• Device Lot Number: R40D84
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/30/2020
• Patient Sequence Number: 1