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

Model Number B12SRT

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch#:unk.Date of event is unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that before an unknown procedure, the package of the inner cylinder had been damaged before the package was opened.The clear part of package was penetrated, resulting in loss of sterility.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 10/28/2020.Investigation summary: the analysis results found that the b12srt device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged.It was noted to be broken and still adhered to the tyvek.Due to the damages found on the blister, a possible cause for this condition is due to improper handling during transit or storage.It appears that the package hit a hard surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information 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: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10589651
• MDR Text Key: 208713875
• Report Number: 3005075853-2020-04932
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: 10705036001188
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12SRT
• Device Catalogue Number: B12SRT
• Device Lot Number: U40C8H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/05/2020
• Patient Sequence Number: 1