MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., MEDIUM, 30°, WITH CABLE, STERILE; HF-ELECTRODES WITH CABLE

Model Number	WA22606D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a hysteroscopic transurethral resection in saline (turis) procedure, the patient sustained a perforation of the uterine wall.The procedure was then converted to open surgery (laparotomy) to treat the perforation.No further information was provided, but there were no reports of any device malfunctions.
Event or Problem Description
Olympus was informed that during a hysteroscopic transurethral resection in saline (turis) procedure, the patient sustained a perforation of the uterine wall.The procedure was then converted to open surgery (laparotomy) to treat the perforation.No further information was provided, but there were no reports of any device malfunctions.The patient recovered and was discharged from the hospital.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of the hf resection electrodes without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., MEDIUM, 30°, WITH CABLE, STERILE
• Common Device Name: HF-ELECTRODES WITH CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8435604
• Report Number: 9610773-2019-00059
• Device Sequence Number: 2249778
• Product Code: FAS
• UDI-Device Identifier: 14042761075470
• UDI-Public: 14042761075470
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K102781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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 Expiration Date: 02/08/2020
• Device Model Number: WA22606D
• Device Catalogue Number: WA22606D
• Device Lot Number: P1710001, P1710002, P1710007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HF UNIT "ESG-400" (WB91051W); OLYMPUS HF UNIT "ESG-400" (WB91051W)
• Outcome Attributed to Adverse Event: Required Intervention