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

Model Number	D5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.
Event or Problem Description
It was reported that during an unknown procedure, the packaging had a hole.There were no patient consequences reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/9/2020.Investigation summary: the analysis results found that the d5st device was returned inside its package.The package was returned partially opened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged and the damaged was noted to be from the outside in.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.Iit appears that the package hit a hard surface and this caused the reported event.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.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: 9691014
• Report Number: 3005075853-2020-00922
• Device Sequence Number: 19509118
• Product Code: GCJ
• UDI-Device Identifier: 10705036001607
• UDI-Public: 10705036001607
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 06/30/2024
• Device Model Number: D5ST
• Device Catalogue Number: D5ST
• Device Lot Number: T40P46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1