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

Catalog Number GST60T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Info anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.Intra-operative photos were received.The evidence in the photos confirms that the cartridge deck has additional material on the top edges that should not be there.It is possible for this extra material to have propagated a tear in the buttress material.Unfortunately, the root cause of the issue cannot be determined based on the photos.Based on the photographic evidence, the event description can be confirmed, but the root cause of the reported event cannot be determined.

Event Description

It was reported that during a laparoscopic gastric sleeve procedure, the black gst cartridge was loaded into the plee60a device.Then, when sliding the gore seamgaurd buttressing onto the cartridge, the buttressing ripped.It appeared that the molding on the cartridge deck was flawed; it was like a piece of the plastic was never put on top of the deck.The cartridge was not used for the patient.The case was completed with the same endocutter and additional cartridges.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # m53h0n.The analysis results showed that one gst60t cartridge reload was received unfired.Upon further inspection the returned reload was noted to have the alignment stop tabs damaged.It is possible that the tabs were damaged due to an improper loading technique.Please note that to insert a new reload, slide it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.Snap the reload securely in place.Remove the staple retaining cap and discard.The cartridge was loaded into a test ec60a device and was tested for functionality in the articulated position and achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.A batch record review was performed and no anomalies were found during the manufacturing process.

• 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: 5010742
• MDR Text Key: 24529652
• Report Number: 3005075853-2015-05162
• Device Sequence Number: 1
• Product Code: GDW
• 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: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2020
• Device Catalogue Number: GST60T
• Device Lot Number: M4HN9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1