MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE SKIN STAPLER; REMOVABLE (SKIN)

Catalog Number PXXXX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Organ Dehiscence (2502); No Code Available (3191)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: who placed the staples during the procedure: one of the surgeons; what is his/her experience with the device: unsure, per the operating room manager she is sure it is years since the account has used the same brand stapler for years with no problems; what technique was used in applying the staples, was the skin everted: unaware; what is the current patient status: patient was discharged home on (b)(4).

• Brand Name: PROXIMATE SKIN STAPLER
• Type of Device: REMOVABLE (SKIN)
• 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: 6419186
• MDR Text Key: 70406117
• Report Number: 3005075853-2017-01542
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• PMA/PMN Number: K833357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention