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

Model Number	EC45
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only month and year are known.It is assumed first day of the month (month) that the complaint was received.Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information was requested, and the following was obtained: does the patient have known metal allergy? no at the time of stapler use.Has any metallurgic allergy testing been conducted? if so, could results be shared? unknown.Have other sources of allergens been tested? unknown.How has the patient been treated? unknown.
Event or Problem Description
It was reported by the healthcare professional, "one of our patients who had nephrectomy one year ago has had generalized rash since the surgery.Echelon endopath was used for arterial and venous stapling.".

• Brand Name: ECHELON 45 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11964970
• Report Number: 3005075853-2021-03186
• Device Sequence Number: 19764144
• Product Code: GDW
• UDI-Device Identifier: 10705036001669
• UDI-Public: 10705036001669
• Combination Product (Y/N): N
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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 Model Number: EC45
• Device Catalogue Number: EC45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention