MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENDOPATH XCEL; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	H12LP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged female undergoing procedure: examination under anesthesia, operative laparoscopy, lysis of adhesions, unilateral salpingo-oophorectomy, hysterectomy and cystoscopy.During procedure, a gray button/cap popped of the device.

• Brand Name: ENDOPATH XCEL
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 9763455
• Report Number: 9763455
• Device Sequence Number: 19534777
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: (01)10705036002017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/20/2020
• Report Date (Section F): 02/20/2020

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 Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: (17)241231(10)U4010X
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 52
• Date Report Sent to FDA: 02/20/2020