MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE

Model Number WA02944A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Excessive Tear Production (2235)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation found that there are no sharp edges or burrs on the distal tip.The exact cause of the patient's outcome could not be determined, as there was no device damage that would likely cause or contribute to the reported event.The instruction manual states: "visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches." if significant information is received at a later time, this report will be supplemented.

Event Description

Olympus was informed that during an unspecified procedure, the patient's ureter was torn.There was minimal bleeding reported.No additional information was provided.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no results.

• Brand Name: URETEROSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrabe 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5335922
• MDR Text Key: 34736149
• Report Number: 2951238-2015-00629
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015

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: Physician
• Device Model Number: WA02944A
• Device Catalogue Number: WA02944A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• 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
• Patient Outcome(s): Other