MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 440MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PLEE60A

Device Problems Crack (1135); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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.Photographic analysis: one photo was provided; the picture shows four cartridges from a top view.3 blue cartridges and one yellow cartridge.The four cartridges are fully fired.The first blue cartridge from the right has the cartridge deck damaged.Based on the photo alone the event describe is confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy, the doctor fired the stapler with one gold reload and one blue reload with no issues.On the third firing with a blue reload, all of the staples did not deploy into the tissue.The knife cut with no issues.A fourth and last firing of the stapler with a blue reload was used and not all of the staples deployed.The doctor removed the cartridge, the scrub tech noted the cartridge was cracked.The staple line was reinforced with suture to prevent leakage after the stomach was removed and inspected.The procedure was extended ten minutes due to suture oversewing.There were no patient consequences reported.

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7518248
• MDR Text Key: 108493259
• Report Number: 3005075853-2018-09915
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014611
• UDI-Public: 20705036014611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/24/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: PLEE60A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1