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

Catalog Number EPS03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a laparoscopic unknown procedure, the device was not activated from the beginning.Another eps03 and another eph02 were used to complete the case.There were no adverse consequences to the patient.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7485560
• MDR Text Key: 107453168
• Report Number: 3005075853-2018-09548
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036012471
• UDI-Public: 20705036012471
• Combination Product (y/n): N
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EPS03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1