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

Catalog Number	CB5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information was requested, and the following was obtained: did the hole in the packaging compromise the sterility of the device? the hole was found to be obvious with a puncture on the package, causing concern about the sterility.Device analysis: the analysis results found that cb5st device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was noted to be from the outside in.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.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 n4l45v number, and no non-conformances were identified.
Event or Problem Description
It was reported that the unopened package of the trocar was damaged with a small hole before using on the patient.There were no patient consequences.

• Brand Name: 5MM XCEL STABILITY SLEEVE
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8514157
• Report Number: 3005075853-2019-18097
• Device Sequence Number: 16843622
• Product Code: GCJ
• UDI-Device Identifier: 10705036001355
• UDI-Public: 10705036001355
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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 Expiration Date: 01/31/2021
• Device Catalogue Number: CB5ST
• Device Lot Number: N4L45V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1