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

Catalog Number EPS03

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

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 bowel procedure, when the device was handed to the surgeon, the surgical tech noticed that the "l" hook was missing from the tip of the device.A second like device was used to complete the procedure with no patient consequences reported.

Manufacturer Narrative

(b)(4).Device was received on 11/12/2018.

Manufacturer Narrative

(b)(4).Batch # r93687.The device was received with the electrode not present and not returned.The instrument was disassembled and it was noted that the electrode was fully missing.It could not be determined what may have caused the incident reported.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8034096
• MDR Text Key: 126664464
• Report Number: 3005075853-2018-14140
• Device Sequence Number: 0
• Product Code: GCJ
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: EPS03
• Device Lot Number: R9398W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 11/12/2018; 12/12/2018
• Supplement Dates FDA Received: 11/29/2018; 12/21/2018
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDLE