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

Catalog Number ECR60D

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # m53c19.(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Photographic analysis: the analysis results found that only a photo for analysis was received.The picture shows an ecr60d cartridge reload, out of its sterile package, unfired and what seems to be a cartridge driver out of its intended position.The reported event could not be confirmed as no cartridge sample was returned for analysis.It should be noted that all reloads are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.The reported event could not be confirmed as the device performed without any difficulties noted during the functional testing.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

Event Description

It was reported that during a gastric sleeve procedure, "at the moment of connect the reload to the stapler, the reload is checked and it is observed that the reload is bad conditions." it is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Batch # m53884.Manufacturer date: 4/13/2015.Expiration date: 3/13/2015.The analysis results showed that one ecr60d cartridge reload was returned unfired, with 3 drivers missing and 1 driver out of position making the reload non-functional.Although no conclusion could be reached on what caused the drivers to fall, it is possible that the package was not opened using the sterile technique resulting in the drivers dislodging from the reload.In addition it should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.A batch record review was performed and no anomalies were found during the manufacturing process.

• Brand Name: ENDO LINEAR CUTTERS
• 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: 5100271
• MDR Text Key: 26852838
• Report Number: 3005075853-2015-06089
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

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: 03/13/2020
• Device Catalogue Number: ECR60D
• Device Lot Number: M4HK90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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