MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 340MM SHAFT; STAPLE, IMPLANTABLE

Model Number PSEE60A

Device Problems Use of Device Problem (1670); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information was requested and the following was obtained: how much bleeding were there approx.Ml? unknown.How was it managed? i believe it was sutured but i can check on this.Any changes to patient¿s bp? unknown.What procedure was it? sleeve gastrectomy.What was the appearance of the deployed staples (b-formed, malformed, goal.Post/legs straight)? few staples can be seen that's straight.In addition, reload.Selection for the last firing may have not been ideal (she used green for each of the 5 firings).Were there staples missing from the staple line? not noted.Additional information: upon visual inspection of one video, the following was observed the video shows a device with a green reload loaded at the 19:11 mark of video.The device shows a buttressing on the jaws.At the 19: 27 mark the tissue is placed between the jaws.At the 20: 28 mark the device is firing.At the 20:38 mark the jaws are open and removed of tissue.The cut and staple line are as expected.At the 21:29 mark a device is introduced with a green reload loaded and buttressing on the jaws.At the 21: 36 mark the tissue is placed between the jaws.At the 21: 50 mark the jaws are closed.At the 22: 34 mark the device is firing.At the 22: 41 mark the device is removed of tissue.The cut and staple line are as expected.At the 23:56 mark a device is introduced with a green reload loaded and buttressing on the jaws.At the 24: 02 mark the tissue is placed between the jaws.At the 24: 07 mark the jaws are closed.At the 24: 49 mark the device is firing.At the 24: 56 mark the device is removed of tissue.The cut and staple line are as expected.At the 25:54 mark a device is introduced with a green reload loaded and buttressing on the jaws.At the 26: 05 mark the tissue is placed between the jaws.At the 26:53 mark the jaws are closed.At the 27:40 mark the device is firing.At the 27:48 mark the device is removed of tissue.The cut and staple line are as expected.At the 28:50 mark a device is introduced with a green reload loaded and buttressing on the jaws.At the 29: 07 mark the tissue is placed between the jaws.At the 29:19 mark the jaws are closed.At the 30:12 mark the device is firing.At the 30:20 mark the device is removed of tissue.The cut and staple line are as expected.However, slightly bleeding could be observed along of staple line.At the 31:03 mark a device is introduced with a green reload loaded, without buttressing.At the 31: 15 mark the tissue is placed between the jaws.At the 31:27 mark the jaws are closed.At the 31:45 mark the device is firing.At the 31:54 mark the device is removed of tissue.At the 32:13mark bleeding is noted on the distal end of staple line.Also, at the 32:26 mark a staple what appears to be not properly formed on the tissue.At the 35:38 mark a device is introduced with a green reload loaded and buttressing on the jaws.At the 36: 05 mark the tissue is placed between the jaws.At the 36:07 mark the jaws are closed.At the 37:05 mark the device is firing.At the 37:13 mark the device is removed of tissue.The cut and staple line are as expected.At the 40:03 mark bleeding is noted on the tissue.Based on the photo the event describe 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a sleeve gastrectomy procedure, surgeon advised that last week she was using the powered echelon, which worked fine for the initial firings.On the last firing, it appeared to fire properly but once she removed the device the staple line was bleeding and upon closer inspection, all layers of the muscosa has not been captured.Dr.Continued to use the device with no issues in consequent firings.The patient's outcome was positive and they had no issues.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10518408
• MDR Text Key: 206566930
• Report Number: 3005075853-2020-04592
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1