MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number	A22026A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	06/22/2018
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 user's experience 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 therapeutic transcervical resection of the endometrium in saline (tcris) procedure, the patient sustained a perforation of the uterus.It is suspected that this injury was caused by excessive force applied on the resectoscope.The procedure was then converted to a laparoscopic procedure to treat the perforation.No further information was provided but none of the olympus medical devices showed any malfunction and the procedure was reportedly completed after the intervention.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
• Common Device Name: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 7654121
• Report Number: 9610773-2018-00064
• Device Sequence Number: 1550872
• Product Code: GCP
• UDI-Device Identifier: 04042761029346
• UDI-Public: 04042761029346
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• 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
• Report Date (Section B): 07/02/2018

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: A22026A
• Device Catalogue Number: A22026A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/02/2018
• 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 WORKING ELEMENT, PASSIVE ((B)(4))
• Outcome Attributed to Adverse Event: Required Intervention