MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 28CM SHAFT; STAPLE, IMPLANTABLE

Model Number	PCE60A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, noted the spring falls off.Changed to a new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pce60a device was returned with no apparent damage and with no reload present.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence.The staple line and cut line were complete and the staples meet the staple form release criteria.Upon further inspection, the firing trigger would not function as intended and felt loose.In order to verify the condition of the internal components, the device was disassembled, and the spring firing trigger was noted to be out of its intended position.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the spring firing trigger is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 584a11, and no non-conformances were identified.

• Brand Name: PWRD ECH FLEX 60MM 28CM SHAFT
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16298766
• Report Number: 3005075853-2023-00760
• Device Sequence Number: 5991650
• Product Code: GDW
• UDI-Device Identifier: 10705036014478
• UDI-Public: 10705036014478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110385
• 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
• Report Date (Section B): 02/03/2023

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 Expiration Date: 11/14/2024
• Device Model Number: PCE60A
• Device Catalogue Number: PCE60A
• Device Lot Number: X9414D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown