MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number EC60

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p56j5d.Per photographic evaluation: upon visual inspection of the picture, the tyvek can be noted to be separated from the blister.However, no definitive conclusion could be reached as to the origin of the damage as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Device analysis: the analysis results found that an ec60 device was returned inside its package partially opened.Upon visual inspection, it was observed that the blister and the tyvek from the packaging were damaged; the blister was found to be bent and the tyvek was noted to have a hole.The sterility was compromised.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.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.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

Packing breakage.Opened the outbox, found the packing damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7499598
• MDR Text Key: 107994019
• Report Number: 3005075853-2018-09721
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036001697
• UDI-Public: 20705036001697
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• 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: 03/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: EC60
• Device Lot Number: P92L5L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1