MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH

Model Number A22040A

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

No device returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To prevent device failure and patient injury, the device instructions for use document has pre-procedure directions to inspect for damage and corrosion, and states ¿visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).¿ the instructions for use also warns, ¿impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.¿ and ¿if the obturator¿s distal end does not move when inserted into the patient, do not try to remove the obturator from the sheath.Remove the entire sheath/obturator assembly from the patient.Otherwise, the sheath¿s distal end may be damaged.¿.

Event Description

Olympus was made aware that a patient was injured during a procedure involving a resection scope.He stated that the ceramic tip of the inner sheath broke off on the way into the patient.The sharp edges cut the urethra and causing the patient to bleed excessively.The procedure was cancelled.

Manufacturer Narrative

The oem performed the device evaluation based on the information provided by the customer.The reported type of damage to the sheath leads to assume that the insulation tip's fracture was caused by thermal/mechanical influence.Most likely a stress crack developed vertically through the insulation insert leading to insulation beak completely tearing off.It cannot be determined, whether undiscovered damage already existed prior to the tip breaking.Service center have assessed the risks and hazards associated with this fault as acceptable.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.As for the technical cause, it is assumed that damage to the tip of the sheath was caused by thermal/mechanical overload in combination with wear.In addition, a dhr review was performed and showed that no non-conformities or deviations regarding the described issue.

Event Description

The procedure that was being performed was a transurethral resection prostate.The device was inspected and there were other instruments such as the inner sheath and resection loop.Only this device was damaged.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8299529
• MDR Text Key: 134856054
• Report Number: 2951238-2019-00404
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 188W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other