MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 28 FR.; RESECTOSCOPE

Model Number	A22043A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not yet been received by olympus for evaluation (although it is anticipated).The definitive cause of the users experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a transurethral resection of the prostate (turp) using a wa22067a passive working element, an a22043a 28fr resection sheath, an a0393 monopolar high frequency (hf) cable, an a22087a 28fr deflecting tip obturator, and an a22052a rotatable luer-lock irrigation port, the grounding pad was not placed properly on the patients leg and the patient experienced a serious burn.The burn occurred during the procedure as the urologist activated the electrode to resect prostate tissue.The procedure was cancelled due to the burn.It is not known what intervention was required to treat the burn.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.(b)(6) reports the wa22067a.(b)(6) reports the a0393.(b)(6) reports the a22087a.(b)(6) reports the a22052a.(b)(6) reports the a22043a.
Additional Manufacturer Narrative
This report is being updated to provide additional information and corrected information.
Event or Problem Description
Update: the customer clarified 02jul2021 that the customer does not use an olympus generator or olympus grounding pads.The burn experienced by the patient is not related to the use of an olympus device.

• Brand Name: RESECTION SHEATH, 28 FR.
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12063800
• Report Number: 9610773-2021-00172
• Device Sequence Number: 19987512
• Product Code: FJL
• UDI-Device Identifier: 04042761021005
• UDI-Public: 04042761021005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: A22043A
• Device Catalogue Number: A22043A
• Device Lot Number: 05XW-0003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other