MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D11LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.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
It was notice prior to an unknown procedure (preop) that the xcel trocar packaging was damaged and not glued well on side of packaging.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/22/2020.Additional information received: two photos were received for review.Upon visual inspection of two photos, the following was observed: the photos show a tyvek of product code d11lt and the tyvek can be seen with wrinkles, however, no damages could be observed on the tyvek or seal area.Based on the photos reviewed, the event described cannot be confirmed.Hands-on analysis may provide the additional evidence necessary to confirm the root cause of the reported event, however no actual packaging has yet been received for analysis.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10610376
• Report Number: 3005075853-2020-05073
• Device Sequence Number: 1152209
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: D11LT
• Device Catalogue Number: D11LT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1