MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO ILS 21MM, CURVED; STAPLE, IMPLANTABLE

Model Number	ECS21A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was received: was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? yes.Could you please identify the packaging (primary packaging, box, pouch seal or the plastic bag)? primary packaging.Could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, contain cut or slit, or appear ripped)? a hole on the package.5.Did the damage of the primary packaging compromise the sterility of the device? yes.Per photographic evaluation: this is an analysis of a photo submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the photo shows a tyvek of product code: ecs21a and damages can be seen on the tyvek.Also, the damages are from outside to inside.Based on the photo the event described is confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the ecs21a device was returned outside of its package, only a tyvek was returned along with the device.Upon visual inspection, it was observed that the tyvek from the packaging was damaged (holes) and also the staple retainer was noted to be damaged; the damage found on the tyvek compromised the device's sterility.The reported event is confirmed.Due to the damages found on the packaging, 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.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s 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 before the surgery, before used on the patient, the package was found damaged.Changed another one to complete surgery.There was no patient consequence reported.No additional information can be provided.Procedure: right hemicolectomy.

• Brand Name: ENDO ILS 21MM, CURVED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15727654
• Report Number: 3005075853-2022-07519
• Device Sequence Number: 2919499
• Product Code: GDW
• UDI-Device Identifier: 10705036003489
• UDI-Public: 10705036003489
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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 Model Number: ECS21A
• Device Catalogue Number: ECS21A
• Device Lot Number: X94V7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown