MAUDE Adverse Event Report: GYRUS ACMI, INC USA ELITE RIGID OPTICAL GRASPING FORCEPS

Model Number E8215

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to olympus for evaluation.The exact cause of the reported event cannot be determined.However, based on similar reports, the operator¿s technique cannot be ruled out as a contributory factor to the reported event.The instruction manual warns user¿s that ¿excessive squeezing force on handles can lead to failure of forceps jaws.¿.

Event Description

Olympus received a medwatch report that indicates during a therapeutic cystourethroscopy with holmium laser cystolitholapaxy procedure, the grasper jaw broke off and fell into the patient¿s bladder.It was reported that the surgeon was removing stones when the grasper broke.The device fragments were retrieved with an unknown device.There was no bleeding reported.The intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results and to update the device lot number.The device was returned to olympus for evaluation.The user¿s complaint was confirmed.A visual inspection was performed on the received device and found the grasper jaw and link assembly broken off at the distal end.The broken off jaw and link assembly unit were not returned with the device for evaluation.No other anomalies were found with the device.Based on the evaluation, the broken jaw link assembly is due to excessive force attributed to mishandling.

• Brand Name: USA ELITE RIGID OPTICAL GRASPING FORCEPS
• Type of Device: RIGID OPTICAL GRASPING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7053691
• MDR Text Key: 93690799
• Report Number: 2951238-2017-00745
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: E8215
• Device Catalogue Number: E8215
• Device Lot Number: EW
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/10/2018
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1