MAUDE Adverse Event Report: GYRUS ACMI INC, RIGID 3-PRONG GRASPING, 4MM, 37CM; RIGID 3 PRONG GRASPING FORCEPS

Model Number RPG-437

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information or if the device is received at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a percutaneous nephrolithotripsy procedure, the surgeon was attempting to deploy the grasper and upon released of the handle, the three prongs on the device broke and fragmented and scattered inside the patient.The surgeon used a second grasper and successfully retrieved all three prongs.To ensure that nothing remained inside the patient, the surgeon also irrigated the patient's kidneys and ordered a post-surgery cat scan and no device fragments were observed.The intended procedure was successfully completed with another similar device.There was no patient injury reported.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The reported complaint was confirmed.The three broken prongs were not returned at the time of investigation.A visual inspection was performed on the device and found minor rust at the notched end of the wire shaft, and some slight scratches on both distal ends of the working channel and on the wire shaft.However, the wire shaft could be inserted or slid distally out of the sheath without restriction.Both working channel and the wire shaft are straight with no physical impact, bend or protrusions.The handle is also functional.The exact cause of broken prongs could not be conclusively determined at this time.Since the device is designed to be reusable the most likely cause of the reported event can be attributed to the cleaning, disinfecting, and sterilizing processes.Also, multiple usages would cause the prongs to become worn out and weak; therefore, any weak spots could cause the prongs to snap off when excessive force is applied during use.The instruction manual contains several warning statements in an effort to prevent device damage: "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Follow the disinfectant or sterilizer manufacturer's recommended procedures and cautions.Do not use disinfectant solutions that contain long-life surfactants; such solutions can leave conductive residues.".

• Brand Name: RIGID 3-PRONG GRASPING, 4MM, 37CM
• Type of Device: RIGID 3 PRONG GRASPING FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC,; 136 turnpike road; southborough MA 01882 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5006392
• MDR Text Key: 24429438
• Report Number: 2951238-2015-00366
• Device Sequence Number: 1
• Product Code: FGO
• 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: Physician
• Report Date: 09/25/2015

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: RPG-437
• Device Catalogue Number: RPG-437
• Device Lot Number: 46160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2015
• 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