MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, CURVED; STAPLE, IMPLANTABLE

Model Number CDH25A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.  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.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify, if possible, was the device used previously and then resterilized and put back into its original packaging? 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 Description

It was reported that the hospital noted the out box was not sealed, checked the sterile packing, it was sealed but not very well, because when opened the sterile packing, noted some site was not sealed, checked the device, the washer was cut off and the cartridge was without any staples.There were no adverse consequences to the patient.No additional information could be provided.

Manufacturer Narrative

(b)(4).Date sent: 01/13/2020 d4: batch # t5e113 additional information was requested, and the following was obtained: can you please clarify, if possible, was the device used previously and then re-sterilized and put back into its original packaging? no.The device has never been used or open the packing before.Per photographic evaluation: upon visual inspection of seven photos, the following was observed: the first and second photos shows a device from anvil area and the washer can be seen cut.The third photo shows an ils 25 device from handle area and safety can be seen disengaged.The fourth photo shows a device from top view inside of blister without tyvek.The fifth photo shows a box of product code cdh25a with a device inside its package and part of tyvek can be seen missing that allow see the device inside of package.The sixth photo shows a device from anvil area with the knife and drivers exposed and without staples present and the washer cut; indicating that the device achieved a full firing stroke.The seventh photo shows a device from anvil area partially open and the washer could be observed cut.Based on the photos no conclusion could be reached as to what may have caused the reported incident, the assignable cause of the reported complaint could not be determined.Please refer to the device analysis for full analysis details and conclusion.Device analysis: the analysis results found that the cdh25a device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.In addition, a tyvek was received cut on the middle part and complete detached of the blister.Due to the damages found on the tyvek, a possible cause for these conditions is due to improper handling.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.It should be noted that all devices are inspected 100% for staple presence by an automated vision system and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ILS 25MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9506218
• MDR Text Key: 202575818
• Report Number: 3005075853-2019-24678
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: 10705036003458
• Combination Product (y/n): N
• PMA/PMN Number: K983536
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDH25A
• Device Catalogue Number: CDH25A
• Device Lot Number: T40X33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1