MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 45 STANDARD; STAPLE, IMPLANTABLE

Catalog Number ECH45S

Device Problems Material Separation (1562); Component or Accessory Incompatibility (2897)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that during an lar procedure, surgeon reported incident where the articulation joint covering is getting caught and then damaged by the trocar edge.He said that they are pressing the home button but thinks that because it is slightly off centre this is what is causing the damage.Device had been fired a few times at full articulation, and then removed ; the damage trying to remove it from the reusable 12mm port was significant enough that the black plastic piece tore off and they had to find and remove from the abdomen.Staff are not sure how to proceed given that they have these reusable trocars that are meant to fit 12mm instrumentation.The surgery was delayed by an uncertain amount of time.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Date sent: 3/4/2024.3: exact event date unk, entered 1/1/2024 as only the year was provided.D4: batch # unk.Investigation summary: this is an analysis of six photos and a video submitted to ethicon endo-surgery for evaluation.During the visual analysis, the following was observed: the photos show a device 45 mm with the joint cover damaged.The video shows a device 45 mm with the joint cover damaged and it can be seen how the device cannot be easily extracted through the trocar.Based on the photos and the video the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.

Manufacturer Narrative

(b)(4).Date sent: 6/5/2024.D4: batch # 642c62.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 ech45s device was returned with the joint cover damaged, with the anvil slightly bent upwards, and with a gst45w reload present.The reload was received fully fired.As additional testing, the device was tested for functionality in the straight position with a test reload 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.However, the cut was noted to be jagged due to a damaged knife.The device event log was reviewed and showed that the device had a high force to fire for one of the clinical firings, indicating that the device was firing over an obstruction, or too thick of tissue.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.It is possible that the device was clamped over an excess of tissue causing the anvil to bend.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated. repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device. additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 642c62, and no non-conformances were identified.

• Brand Name: ECHELON 3000 45 STANDARD
• Type of Device: 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 ; PR ; 3035526892
• MDR Report Key: 18826550
• MDR Text Key: 337524439
• Report Number: 3005075853-2024-01841
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036035008
• UDI-Public: 10705036035008
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K213633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ECH45S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1