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

Model Number EPS07

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.Attempts are being made to obtain the device.To date no device has been received.If further details are received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that, during a total laparoscopic hysterectomy, the shaft was broken off during use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 02/20/2020.D4: batch # t9452n.Device analysis: the device was received with no apparent damage, the electrode tip was intact and not broken off as reported by the customer.The instrument was tested for continuity and was found to be conforming.There were no anomalies noted with the functionality of the device.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9599345
• MDR Text Key: 199899022
• Report Number: 3005075853-2020-00389
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012511
• UDI-Public: 10705036012511
• 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,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPS07
• Device Catalogue Number: EPS07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/22/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR.