MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Model Number	EC60
Medical Device Problem Codes	Failure to Cut (2587); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch#: r57f3a.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.Could you please specify how the device jammed? was the device locked on tissue with the jaws closed? if yes, how was the device removed? did the jaws eventually open? investigation summary: 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 determined that one ec60 device was returned with no apparent damage with an ecr60b reload loaded in the device.The reload was received partially fired 1/16.Upon evaluation of the reload, the reload pan was removed and it was noted that the one-piece sled was damaged.No obvious damage to the reload deck was noted, which suggests the reload, may not have been fired over a hard object.As additional testing, the device was tested for functionality with a test reload and it achieved a complete 3-strokes fire without any difficulties noted.The staple line and cut line were complete and the staples meet the staple release criteria.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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number: r57f3a, and no non-conformances were identified.
Event or Problem Description
It was reported that the knife didn't cut to the end.After triggering a second time, the device was jammed.No patient harm nor significant delay reported.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• 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: 16397007
• Report Number: 3005075853-2023-01053
• Device Sequence Number: 12148556
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051002
• 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): 02/17/2023

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: 01/31/2021
• Device Model Number: EC60
• Device Catalogue Number: EC60
• Device Lot Number: R57F3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown