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

Model Number E8215

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The device was visually inspected and it was found that the jaw of the grasping forceps had broken off at the distal tip.It was also noted that the link assembly was broken off and damaged.However, the broken jaw was not returned for investigation.This type of phenomenon can be contributed to impact damage by use of excessive force which causes the jaw to break off.The instruction manual warns users: "excessive squeezing force on the handles can lead to the failure of the forceps jaw.".

Event Description

Olympus was informed that an during unspecified procedure, the surgeon was grasping a stone when the grasper broke and fell inside the patient.The surgeon irrigated the bladder and the grasper piece was flushed out and onto the draping.The intended procedure was not completed due to the large size of the stone.The patient was rescheduled for another procedure at a later time.There was no patient injury reported.No additional information was provided.

• 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 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4998680
• MDR Text Key: 22833165
• Report Number: 2951238-2015-00357
• 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: 07/24/2015

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: E8215
• Device Catalogue Number: E8215
• Device Lot Number: DJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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