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

Catalog Number	SC60
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch number: p55m2e.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.Additional information requested and received: what were the indications for surgery? bullae of right upper lobe please describe tissue condition.What does it mean "tissue condition"? was the device difficult to close? no.Was the device difficult to fire? yes.Did the surgeon require two hands to fire device? no.Does the surgeon believe that the tissue was excessively thick or dense? no.What is the current patient status? stable and left from the hospital.
Event or Problem Description
It was reported that the staples malformed after firing.During the thoracoscopic resection of bullae of superior lobe of right lung, after 1st fired with sc60 and ecr60b, the staples malformed with irregular shape.Changed another ecr60b, the event re-happened.Changed ec60 with ecr60d, the event re-happened.Changed ec60a with ecr60d, the event re-happened.The patient lost about 200ml blood without transfusion.The surgery was changed to open surgery, and delayed about 30 minutes.Used tlc75 to complete the surgery.The patient is stable and in hospital now.
Additional Manufacturer Narrative
(b)(4).Batch number: p55m2e.Investigation summary: the analysis results found that one sc60 device was returned with no apparent damage and with no cartridge reload present.The device was tested for functionality with a test cartridge reload and achieved its complete 3-stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7053051
• Report Number: 3005075853-2017-06280
• Device Sequence Number: 11065588
• Product Code: GDW
• UDI-Device Identifier: 20705036002700
• UDI-Public: 20705036002700
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: SC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR