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

Catalog Number	EPS02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary the device was received with the detent spring component missing.Due to the returned device condition no functional testing could be performed.However, the instrument was tested for continuity and was found to be conforming.It is possible that this issue could occur during our manufacturing process.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an unknown procedure, the device was not activated.Another 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: 7338093
• Report Number: 3005075853-2018-08530
• Device Sequence Number: 1657785
• Product Code: GCJ
• UDI-Device Identifier: 20705036012464
• UDI-Public: 20705036012464
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient 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 Expiration Date: 08/31/2022
• Device Catalogue Number: EPS02
• Device Lot Number: P93R21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1