MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNKNOWN PRODUCT OR FAMILY; STAPLE, IMPLANTABLE

Catalog Number CDHXX

Device Problems Failure to Fire (2610); Torn Material (3024)

Patient Problem Colostomy (2552)

Event Date 08/31/2012

Event Type  Injury  

Event Description

Received notice of litigation against the surgeons, hospital and ethicon.Pleading alleges that during an unknown procedure using an unknown stapler, ¿the stapler failed to fire properly¿ during surgery on patient¿s bowel, and his bowel ¿became trapped in the stapler and could not be removed until it was torn away¿.Pleading further alleges that as a result of this incident, ¿bowel necrotized and was pulled from his anus and he has had to use a colostomy bag¿ and that patient ¿faces an increased risk of serious injury or death if the colostomy bag tears away or is damaged.¿.

Manufacturer Narrative

(b)(4).Information was not provided by the contact.Information is unavailable; device was not returned for evaluation.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN PRODUCT OR FAMILY
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4148167
• MDR Text Key: 4769465
• Report Number: 3005075853-2014-06901
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDHXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention