MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Model Number CDH33A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2020.Batch #unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the inner package had not been sealed.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 05/21/2020.Device analysis: the analysis results found that cdh33a device was returned with the tyvek not properly seal from a corner on the blister, and the seal area was noted with a channel open.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.

Manufacturer Narrative

(b)(4).Date sent: 08/18/2020 additional analysis performed by the tyvek supplier.Analysis at the supplier included 100% visual inspection of all tyvek available from the complaint lot and ftir analysis of the tyvek from the complaint device.All material was found conforming at the supplier and ftir indicated no contamination was present on the packaging from the complaint device.Upon arrival at the cincinnati pi lab, the packaging was visually evaluated to determine the potential cause of the sterile barrier breech for the complaint device.Evaluation in cincinnati found evidence that the channels through the sterile barrier had previously been sealed, indications of seal creep originating at the interior of the seal flange and traveling outward, no areas of significant ropes or veins present in the tyvek, and damage to the secondary packaging which was also received with the primary device packaging.The damage to the secondary packaging was located at one end of the carton and included damage to the bumper within the end tab.Cincinnati analysis confirmed the defect found in the sterile barrier seal and based on the analysis the breech was attributed to a root cause of non-customary handling.

• Brand Name: ILS 33MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9979172
• MDR Text Key: 188382798
• Report Number: 3005075853-2020-02242
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: 10705036003472
• 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,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDH33A
• Device Catalogue Number: CDH33A
• Device Lot Number: T41214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Date Manufacturer Received: 07/28/2020
• Patient Sequence Number: 1