MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396; URETEROSCOPES, AUTOCLAVABLE

Model Number WA29042B

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

There was no device returned to olympus for evaluation/investigation.Therefore, the exact cause of the patients' outcomes and the reported phenomenon could not be determined and is being judged as unknown.The case will be closed from olympus side with no further actions but may be reopened if a device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the reported events/incidents will be recorded for trending and surveillance purposes.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wa29042a; brand name: ureteroscope, 8,6/9,8 fr.X 430 mm, 7°, 6,4 fr.Channel, with wa00396a; common device name: ureteroscopes, autoclavable; 510(k): k951855; product code: fgb.

Event Description

Olympus was informed that after unspecified endoscopic procedures at unknown dates, seven patients developed a urinary tract infection.No further information was provided and the cause of this complication is unknown as well.

• Brand Name: URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396
• Type of Device: URETEROSCOPES, AUTOCLAVABLE
• 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 ; 4940669662
• MDR Report Key: 6180308
• MDR Text Key: 62545293
• Report Number: 9610773-2016-10008
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK951855
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA29042B
• Device Catalogue Number: WA29042B
• Other Device ID Number: 04042761068376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/16/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention