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 Adhesion(s) (1695); Nausea (1970); Vomiting (2144); Surgical procedure (2357); Obstruction/Occlusion (2422)

Event Date 07/16/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent laparoscopic repair of recurrent incarcerated incisional hernia on (b)(6) 2014 and absorbable staples were used to secure the mesh.It was noted the patient had several loose adhesions of incarcerated omentum inside the hernia at the time of surgery.On (b)(6) 2014, the patient experienced nausea and vomiting.Radiologic studies were performed and identified a small bowel obstruction.Patient was treated conservatively with iv nutrition but was not able to tolerate a full diet.The patient underwent laparoscopic lysis of adhesions on (b)(6) 2014.The patient had extensive and ¿extraordinarily¿ dense adhesions throughout abdomen but most concentrated at periphery of mesh.The surgeon opines that dense adhesion contributed to post-operative small intestine obstruction.The patient is doing well with no recurrence.

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.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: 4068105
• MDR Text Key: 18292413
• Report Number: 2210968-2014-12553
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: STRAP25
• Device Lot Number: HGM174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• 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
• Patient Weight: 90