MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE; OPTICAL FORCEPS

Model Number A20710A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not yet returned to the manufacturer for evaluation/investigation.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral stone retrieval and lithotripsy by laser procedure, the jaws of the suspect medical device could not be closed by operating the handle; whilst attempting to grasp and retrieve the crushed bladder stones.The grasping forceps then had to be removed in open position by the application of increased force.The intended procedure was reportedly canceled and the patient was hospitalized.However, there was no report of patient injury and a follow-up procedure was scheduled for the week after the initial procedure.

Manufacturer Narrative

Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the grasping forceps are damaged and defective.The jaws are seized in the open position and can no longer be closed by operating the handle.The cause of this damage and the subsequent malfunction of the suspect medical device is mechanical overload.This overload led to the transmission rod breaking at its intended fracture point.This overload protection was activated in order to prevent severe damage to the jaws, such as deformation or fracture.Therefore, this damage was attributed to abnormal use/off-label use by mechanical overload.The case will be closed from olympus side, but the reported phenomenon will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and pro re nata retrained to correctly use the olympus medical devices.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE
• Type of Device: OPTICAL FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5398614
• MDR Text Key: 37104865
• Report Number: 9610773-2016-00007
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 124W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR