MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP; STAPLE, IMPLANTABLE

Model Number PVE35A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch#: unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.A follow-up report will be filed as appropriate.

Event Description

It was reported that during a pancreatic resection when they went to remove the device from the box it was already open.A similar device was used to complete the case with no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 12/10/2020.Investigation summary the analysis results found that a pve35a device was returned with no apparent damaged.In addition, the tyvek was returned along with the instrument.Upon visual inspection of the tyvek, no damaged was noted to be on it.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.Event could not be confirmed as no damaged was noted on the tyvek.It should be noted that as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10829098
• MDR Text Key: 216554882
• Report Number: 3005075853-2020-05939
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: 10705036014584
• Combination Product (y/n): N
• PMA/PMN Number: K141952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 11/12/2020
• Patient Sequence Number: 1