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

Catalog Number	EPS07
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a laparoscopic myomectomy, the shaft and the electrode were broken off.The device was used to remove a very big and solid myoma.The shaft was extremely loaded.The broken pieces were retrieved and no pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # r93c1v.Device manufacture date is 5/23/2018.The shaft was received with the electrode tip broken/detached but returned.The instrument was disassembled and it was noted that a portion off the electrode was still attached to the weld.It could not be determined what may have caused the incident reported.A batch history record review was performed and a protocol was created during the manufacturing of this batch, but was not related to the event description.Additionally, no defects or nc's related to the complaint were found during the manufacturing process.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7985657
• Report Number: 3005075853-2018-13775
• Device Sequence Number: 1104983
• 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,Followup
• Report Date (Section B): 10/09/2018

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: 05/31/2023
• Device Catalogue Number: EPS07
• Device Lot Number: R93J6G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1