MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

The reference device was not returned to service center for evaluation.The cause of the reported event could not be determined.The instruction manual has a warning to reduce the risk of injury which states; "impact, fall, shock or similar stress can damage the ceramic insulation at the sheath's distal end.Damaged instruments can cause injuries of the patient and/or user.Do not use the instrument if it is damaged".Manufacturing and quality control review was also performed for the affected lot and serial number and found no non-conformities or deviations regarding the described issue.If additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during a therapeutic transurethral resection of the prostate (turp) procedure when the sheath was inserted and the irrigation was turn on, the tip of the sheath broke.There was mild bleeding with localized coagulation to control the bleeding.There was a 30 minute delay in which additional anesthesia was needed for the patient.A storz resection device was used to replace the broken sheath and complete the intended procedure.

Manufacturer Narrative

Following further information received from the customer regarding the event; the service center was informed that following other devices were used during the procedure; telescope, passive saline working element, inner sheath, outer sheath, stopcock, light guide cable, bi-polar cable, medium plasma loop.There were no adverse outcome to the patient due to the event.Also, the device was inspected visually before use and no abnormalities noted.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8828065
• MDR Text Key: 152467455
• Report Number: 9610773-2019-00093
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 18ZW-0120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention