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

Model Number A22040A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/13/2019

Event Type  Injury  

Event Description

The service center received a medwatch report, mw5092847, on february 26, 2020 for one bipolar resectoscope sheath which tip broke during a procedure.The report was for model a22040a, rigid cystoscope sheath, lot number 131w-0213, that was used by a physician during a rigid cystoscopy.It was reported the urologist observed a gray/silver- colored, half-circle shaped item present in the bladder during the procedure.Upon inspection of the device, urology noted the tip of the bipolar cystoscope sheath was broken and missing.The physician obtained an x-ray, and the patient was transferred to a tertiary site for removal of the broken piece and management of the condition.The medwatch report indicated that this was a serious injury and no further information was provided.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9849865
• MDR Text Key: 184038505
• Report Number: 2951238-2020-00382
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2020,03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 131W-0213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2020
• Device Age: 7 YR
• Date Report to Manufacturer: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention