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

Model Number	ECS33A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Additional information was requested, and the following was received: was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? packing bag seal damaged.Or, was there difficulty opening the packaging material (difficulty removing/peeling back the tyvek)? no difficulty opening the packing material.Could you please identify the packaging (primary packaging, box, pouch seal or the plastic bag)? could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, contain cut or slit, or appear ripped)? broken.Did the damage of the primary packaging compromise the sterility of the device? yes.This is an analysis for two photos submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the first photo shows the bottom of the sales unit and the tyvek.The tyvek shows the (b)(4) lot number and packaging identification.The sales unit can be seen scraped.The second photo shows a device inside of the blister, with open packaging.Based on the two photos review the event describe could be confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the surgery, before used on the patient, noted the packing was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 08/26/2021.D4: batch # u5ac9e.Device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one ecs33a device was returned without apparent damage and unused.However, no blister neither tyvek was returned for analysis.As part of our quality process, the manufacturing records of this lot were reviewed, and the manufacturing standards were met prior to the release of this lot.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event could not be confirmed as no package was received.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12293403
• Report Number: 3005075853-2021-04555
• Device Sequence Number: 3164599
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• PMA/510(K) Number: K940967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 02/28/2025
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: U93U4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1