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 Bleeding (1738); Punctured blood vessels (2025); Therapy/non-surgical treatment, additional (2519)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

It was reported the cannula came off while removing the device, it was not during firing.The strap caused a small amount of bleeding from a small vessel.The bleeding was not a major problem.

Event Description

It was reported that the patient underwent bilateral hernia repair on (b)(6) 2015 and absorbable straps were used to secure the mesh.While fixating the mesh, the strap did not stay in place and a vessel had been hit, which caused bleeding.Suction and irrigation were performed as well as diathermy.The physician opined that the end plastic cap or the end of the metal shaft may have disconnected and contributed to the event.The current patient status is reported as no problem.

Manufacturer Narrative

(b)(4).Conclusion: 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.

Manufacturer Narrative

It was reported that the patient underwent a bilateral hernia repair on (b)(6) 2015 and absorbable straps were used to secure the mesh.While fixating the mesh, the strap did not stay in place and a vessel had been hit, which caused bleeding.Suction and irrigation were performed as well as diathermy.The strap caused a small amount of bleeding from a small vessel.The bleeding was not a major problem.The current patient status is reported as no problem.

• 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: 4749334
• MDR Text Key: 13398448
• Report Number: 2210968-2015-05262
• 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,Followup,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: STRAP25
• Device Lot Number: JAZ169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2015
• 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 Age: 50 YR
• Patient Weight: 85