MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL TRIO 3MM CURVE TIP 14CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information was requested and the following was received: in response to ¿jaws would not open¿: did the surgeon attempt to manually open the jaws with his fingers? yes.Was the device on a vessel/artery when it would not open? was in the abdomen.If yes, how was the device removed? (i.E.Cut off, forced opened) in place in the trocar.Did the surgeon continue the case with this same device? no.Did the patient experience any adverse consequences due to this issue? unknown.(b)(4).

• Brand Name: ENSEAL TRIO 3MM CURVE TIP 14CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8588201
• Report Number: 3005075853-2019-18842
• Device Sequence Number: 2293822
• Product Code: GEI
• UDI-Device Identifier: 10705036000273
• UDI-Public: 10705036000273
• Combination Product (Y/N): N
• PMA/510(K) Number: K072177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1