MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22041A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2017-10-23).The evaluation/investigation confirmed that the ceramic insulation at the distal end of the resection sheath had broken off and cracked.However, no part was missing since all fragments were returned as well.The cause of this damage and the breakage of the ceramic insulation is most likely thermal (excessive high-frequency output power or laser-induced) and mechanical overload in combination with wear.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.It is clearly stated as a warning note in the instructions that impact, fall, shock or similar stress can damage the ceramic insulation at the sheath's distal end and that the instrument must not be used if damaged since otherwise this can cause injuries to the patient and/or user.The user apparently did not follow these instructions since the damage and breakage of the ceramic insulation were caused by thermal and mechanical overload.Therefore, this event/incident was attributed to use error and the case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes.In addition, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

Event Description

Olympus was informed that during cleaning after a therapeutic transurethral resection (tur) procedure, it was noticed that the ceramic insulation at the distal end of the resection sheath had broken off and was missing.An unspecified examination was performed where fragments were noted inside the patient.These fragments were retrieved during a follow-up procedure the next day.It was confirmed that no foreign objects remained inside the patient.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• 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: 7005740
• MDR Text Key: 91206313
• Report Number: 9610773-2017-00124
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 084W
• Other Device ID Number: 04042761020961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2008
• 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
• Treatment: OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22026A)
• Patient Outcome(s): Required Intervention