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

Catalog Number EPS02

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

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 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.

• 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: 7338093
• MDR Text Key: 102455166
• Report Number: 3005075853-2018-08530
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036012464
• UDI-Public: 20705036012464
• Combination Product (y/n): N
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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