MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	B5ST
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Uf/importer report number: (b)(4).Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: could you please specify if the trocar presented any visible damage? or broken parts? could you please confirm that this was found after the procedure? if yes, were all the plastic parts retrieved from the patient? were there any patient consequences? if yes, please describe.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
See user facility medwatch.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/28/2020.H2: additional information received: the customer reported that "the product or packaging was not retained." d10: device available for evaluation? no.
Additional Manufacturer Narrative
(b)(4) date sent: 8/25/2020.H10: corrected data=h10 h10: user facility medwatch was not attached on initial medwatch.(b)(4).

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10425630
• Report Number: 3005075853-2020-04194
• Device Sequence Number: 16771414
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: 10705036001232
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2020

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: No Information
• Device Model Number: B5ST
• Device Catalogue Number: B5ST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 08/24/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 08/25/2020; 08/28/2020
• Patient Sequence Number: 1