MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D5LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and the device.To date no response has been provided and no device received.If the device or further details are received at a later date, a supplemental medwatch will be sent: were there any patient consequences? if yes, please describe.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.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 reported that when the device arrived, the sterile package was 'open.' patient consequence was not reported.
Additional Manufacturer Narrative
(b)(4).D4: batch # unk.Investigation summary.The analysis results found that a d5lt device was returned with not apparent damaged.In addition, the tyvek was returned along with the instrument.Upon visual inspection, it was noted that the tyvek was returned delaminated.In addition, the seal area was noted to be complete.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique; however, no conclusion could be reached as to what may have caused this condition.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

• Brand Name: XCEL DILATING TIP TROCAR 5MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10512410
• Report Number: 3005075853-2020-04558
• Device Sequence Number: 16814885
• Product Code: GCJ
• UDI-Device Identifier: 10705036001591
• UDI-Public: 10705036001591
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: D5LT
• Device Catalogue Number: D5LT
• Device Lot Number: N4LR63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1