MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number STRAP25

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Unspecified Infection (1930); Surgical procedure (2357); Hospitalization required (2580)

Event Date 03/31/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic ipom incisional hernia repair procedure and absorbable staples were used to secure the mesh.Approximately two weeks following the procedure, the patient complained of fluid at the procedure site.The patient was hospitalized and 2 liters of fluid was drained from the abdominal wall.(b)(6) 2014 a reoperation was done.During the reoperation it was noted that the absorbable staples were still in the mesh but without any fixation to the abdominal wall.It was determined that an e-coli infection was present.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3771128
• MDR Text Key: 17389239
• Report Number: 2210968-2014-05251
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: STRAP25
• Device Lot Number: GJK587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention