MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR D/A ATRAUMATIC 5MMX36CM; ACCESSORIES,ARTHROSCOPIC

Catalog Number ED8360-10

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

It was reported that the grasper failed, fragmented while intra-abdominal.No patient injury or complications were reported.

Manufacturer Narrative

The device reported in this mdr is a product of aesculap, and as such should have been reported by them.This event would be considered not reportable for smith & nephew as the agreement states; ¿in accordance with the agreement between aesculap and smith & nephew, aesculap is responsible for submitting medical device report (mdr) to the fda (or any other similar agency or governmental unit which has jurisdiction with the countries in which the affected products are sold) in accordance with regulation 21 cfr 803.¿.

• Brand Name: GRSPR D/A ATRAUMATIC 5MMX36CM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6386159
• MDR Text Key: 69558588
• Report Number: 1219602-2017-00267
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ED8360-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1