MAUDE Adverse Event Report: GYRUS ACMI INC DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Model Number 006889-901

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 07/07/2014

Event Type  Injury  

Event Description

The user facility reported that during a tubal banding procedure the physician stated that when using the falope ring band applicatory, the pt's fallopian tube was transected and had to be cauterized.The pt was send to recovery in stable condition following the procedure.The physician used the short jaw on the top and the long jaw on the bottom; however, per a warning in the instructions for use is states "always grasp the fallopian tube with the shorter inferior tong positioned on the bottom to avoid injury to the tube." add'l training by an olympus rep has been performed on two different occasions, with the physician and the staff on proper grasping techniques.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for eval.If add'l info or if the device is received at a later time this report will be supplemented.

• Brand Name: DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
• Type of Device: APPLICATOR
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer Contact: neomi schamback ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3987573
• MDR Text Key: 4636448
• Report Number: 2951238-2014-00285
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Catalogue Number: 006889-901
• Device Lot Number: MK832100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention