MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PSE60A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 01/07/25 d4: batch #unk attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished pse60a, with lot/batch number c9d96j, and no non-conformances were identified.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 laparoscopic lobectomy procedure, after fired, noted the staples malformed.Changed another one to continue the surgery, the same problem happened again.Changed the new one to complete surgery.There was no patient consequence reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 1/21/2025.D4 batch #798c12.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 determined that one pse60a device was returned with joint cover damaged with one ecr60d reload loaded on the device and with one unfired ecr60d reload(b) present.Additionally, the loaded reload was received with the right side fully fired, the left side partially fired 1/2.Upon evaluation of the reload, the reload body, one-piece sled, and some drivers were noted to be damaged.No obvious damage to the reload deck was noted, which suggests the reload, may have not been fired over a hard object.As additional testing, the device was tested for functionality in the straight position with the returned reload(b) and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.The damage on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Please reference the instruction for use for more information.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the one-piece sled has been correlated to the design.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 798c12, and no non-conformances were identified.

• Brand Name: PWRD ECH FLEX 60MM 34CM SHAFT
• 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 00969 ; 3035526892
• MDR Report Key: 21096345
• Report Number: 3005075853-2025-00211
• Device Sequence Number: 8721803
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: (01)10705036014324(10)C9D96J(17)261231
• 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,Followup
• Report Date (Section B): 01/21/2025

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: PSE60A
• Device Lot Number: C9D96J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECR60D (X2)
• Patient Sex: Unknown