MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	EPS07
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r9357l.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during an unknown laparoscopic procedure, the electrode tip was broken outside the patient.The broken pieces were retrieved.No pieces fell into the patient.Other competitor¿s device was used to complete the case.There were no adverse consequences to the patient.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8017505
• Report Number: 3005075853-2018-14045
• Device Sequence Number: 13798540
• Product Code: GCJ
• UDI-Device Identifier: 10705036012511
• UDI-Public: 10705036012511
• Combination Product (Y/N): N
• PMA/510(K) Number: K912492
• 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
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EPS07
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/29/2018