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

Catalog Number PLEE60A

Device Problem Crack (1135)

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

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information 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.

Event Description

It was reported during the sleeve gastrectomy procedure when opening the device the blister was cracked and the tyvek was pulled back a little, making the account thinking the device was not sterile.A second device was pulled to complete the procedure with no patient consequence.

Manufacturer Narrative

(b)(4).Batch # m53w21.Additional information received: after speaking to the rep the (b)(6) was pulled back and the blister was cracked when the device was pulled out of the individual box.Hope this note clears up the event.The analysis results found that the plee60a device was returned with the blister damaged.The blister was visually inspected and it was found to be broken.Due to the damage found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.The batch record was reviewed and no anomalies were noted 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: 5034290
• MDR Text Key: 25056511
• Report Number: 3005075853-2015-05395
• 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: 08/05/2015

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: 04/29/2015
• Device Catalogue Number: PLEE60A
• Device Lot Number: M91H9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1