MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, F. LITHOTRIPSY,; GRASPING FORCEPS LITHOTR

Model Number A20710A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

Olympus followed up with the user facility regarding the reported event via telephone and in writing but with no result.The device was returned to olympus for evaluation.The evaluation confirmed that the device jaw would not open or close properly.The device was disassembled and further investigation found that jaw tip was detached inside the main body.The root cause for the reported event could not be determined; however, the most likely cause for the reported event can be attributed to excessive force being applied during use.The instruction manual warns users: ¿when used as intended, this product is subject to wear, depending on the intensity of use.¿.

Event Description

Olympus was informed that at the start of a cystoscopy and laser bladder stone procedure, the grasping forceps broke.No device fragment fell in the patient, but the procedure was completed using a different device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the oem's root cause analysis.The a20710a device was used in an off label manner as the grasping forceps was not designed to crack strong stones; a3661 is more suitable for this application.This may be the result of an insufficient training on the special application of lithotripsy devices.The device has overload protection (to avoid jaw breakage inside the patient) which may lead, in certain cases, to incomplete closure of the jaw after overload protection has engaged.Based on the investigation findings, the root cause of the reported event can be attributed to the off label use of the device and the operator¿s technique.The instruction manual provides several warnings to prevent this type of device damage.¿do not use these products for any purpose other than their intended use.Before use, read this manual, the olympus endoscopy system guide, and the manuals for all other equipment which will be used during the procedure.An insufficient understanding of the dangers, warnings, cautions, and information in these manuals can result in death, serious injury, or equipment damage.This product is to be used only in a medical facility by trained medical personnel.".

• Brand Name: GRASPING FORCEPS, OPTICAL, F. LITHOTRIPSY,
• Type of Device: GRASPING FORCEPS LITHOTR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5905503
• MDR Text Key: 54168884
• Report Number: 2951238-2016-00701
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 162W-0013
• Other Device ID Number: 04042761019989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• 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