MAUDE Adverse Event Report: GYRUS ACMI INC. USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS

Model Number E8213

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.A visual inspection of the device showed that the jaw pivot arm was broken off at the attachment section to the jaw.Corrosion was also observed on the jaws and the pivot assembly.This type of corrosion weakens the entire assembly and will cause the jaws to break.The most likely cause of the reported event will be due to corrosion on the jaw assembly due to the device coming in contact with fluid.Please cross reference mfr number: 2951238-2015-00488.

Event Description

Olympus was informed that during an unspecified procedure, the device was used to remove a stent that was stuck in a calcified lesion; however the device was not opening or closing, the surgeon then pronounced it was broken.A second device was used which was also noted by the physician to be broken.A fluoroscopy was ongoing all the time and once the second device was removed, it was visualized that there is a metal piece floating in the patient's body cavity.The physician then used a third similar device to retrieve the broken piece and was also used to successfully remove the stent.No patient injury was reported.No further information was provided.This is two of two reports.

• Brand Name: USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS
• Type of Device: USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5151887
• MDR Text Key: 28305290
• Report Number: 2951238-2015-00489
• Device Sequence Number: 1
• Product Code: GEN
• 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: Nurse
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E8213
• Device Catalogue Number: E8213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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