MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CYSTOSCOPE SHEATH, 25FR.

Model Number A20915A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Despite multiple followup attempts by phone and in writing, no further information is available regarding the name of the procedure, the sequence of events, whether and how the procedure was completed, the patient¿s current state, the role or performance of the separate forceps device in the event, or the make and model number of the broken stone crushing device.It has also not been confirmed if the forceps device is the same device as the stone crusher.The oem performed a review of the device history record and found no related anomalies at the time of manufacturing release.As preventive measures, the instruction document for the cystoscope sheath device specifies the olympus product that is compatible with the device and states that the device is for use with optical forceps and ¿compatible telescope¿.The instruction document also cautions that when withdrawing, ¿make sure that the instrument stopcock is open and the jaws [of the optical forceps] are closed when withdrawing the instrument.Never withdraw the instrument with excessive force.¿ the instruction document also requires pre-procedure inspection and has instructions for the inspection.

Event Description

One of 2.Olympus was informed that during an unknown procedure, the sheath bent while inside the patient, trapping and breaking a stone crusher.The procedure also involved a separate olympus optical forceps device.All device fragments were retrieved from the patient.There was no reported patient injury.

• Brand Name: CYSTOSCOPE SHEATH, 25FR.
• Type of Device: CYSTOSCOPE SHEATH, 25FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7827827
• MDR Text Key: 118812840
• Report Number: 2951238-2018-00496
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761020275
• UDI-Public: 04042761020275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20915A
• Device Catalogue Number: A20915A
• Device Lot Number: 183W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• 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: Reuse
• Patient Sequence Number: 1