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

Model Number A20710A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the event occurred during an unspecified procedure.No device fragment fell in the patient.It was reported that there was no resistance felt on the handle that required force to be applied.The intended procedure was completed with a similar device.There was no patient injury reported.Additionally, it was reported that the device was inspected prior to the procedure and no anomalies were found.The device was not reprocessed prior to the procedure as this was the initial use of the device.No further detail regarding the device was provided.The device was not returned to olympus for evaluation and is being retained by the user facility¿s risk management department.The root cause for the reported event cannot be determined; however, the instruction manual warns users: ¿before use.Make sure that the product has been properly reprocessed, inspected, and tested.¿.

Event Description

Olympus received a mandatory medwatch (mw#1402310000-2016-8031) which indicated the rotating ball on the grasper broke.It was unknown if the device was used in a procedure.The medwatch reported that this same type of phenomenon had occurred before at this facility and the cause was unknown.

• Brand Name: GRASPING FORCEPS, OPTICAL, F. LITHOTRIPSY,
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6001944
• MDR Text Key: 56551532
• Report Number: 2951238-2016-00786
• 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: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 158W-0017
• Other Device ID Number: 04042761019989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1