MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number ECR60D

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The batch history records were reviewed with no anomalies noted during the manufacturing process.

Event Description

It was reported that during laparoscopic sleeve procedure, the cartridge was opened and pan was twisted and pulling off the cartridge it was cracked.Case completed with another device of the same product code.There were no patient consequences reported.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5161979
• MDR Text Key: 29039937
• Report Number: 3005075853-2015-06657
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2015

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 Expiration Date: 04/28/2020
• Device Catalogue Number: ECR60D
• Device Lot Number: M4HK90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1