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

Catalog Number	EPS05
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92m66.Investigation summary: the instrument was received with no apparent issue.The instrument was connected with a generator and pass all functional testing.The account reported that the instrument did not match the packaging identification.The tyvek provided by the account was for an eps07 instrument with a lot of t92r7a.The instrument returned by the account is an eps05 with batch number t92m66.This condition is most likely related to the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that, before an unknown procedure, it was found that the shape of the electrode tip of the device was not a right angle but a hook.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8997885
• Report Number: 3005075853-2019-21841
• Device Sequence Number: 2132475
• Product Code: GCJ
• UDI-Device Identifier: 10705036012498
• UDI-Public: 10705036012498
• 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
• Report Date (Section B): 08/22/2019

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 Catalogue Number: EPS05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1