MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH ONLY

Model Number 27050CA

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Per the customer, the item will not be returned for evaluation at this time.

Event Description

Per medwatch report, #mw5091907, received on 1/6/2020, during a transuretheral resection of the prostate procedure, the physician noticed the gray tip was fragmented.He found 3 pieces in the patients bladder which were retrieved from the patient with a grasper.The instrument was exchanged out and the procedure was completed with no harm to the patient.They used fluoroscopy to ensure no additional pieces were left inside the patient.

• Brand Name: INNER SHEATH ONLY
• Type of Device: INNER SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9645088
• MDR Text Key: 181724566
• Report Number: 9610617-2020-00013
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/29/2020
• 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 Age: 56 YR
• Patient Weight: 100