MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE,

Model Number WA22302D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, patient's outcome 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 Description

Olympus was informed that during a therapeutic transvaginal uterine fibroid resection procedure at an unknown date around 2018, it is suspected that the patient has suffered an intestinal injury although the muscle layer was scraped and no obvious perforation was made.The intended procedure was completed with an intervention procedure on the next day when the injury of the intestine was sutured.No further information was provided and there was no report of malfunction for any of the olympus medical devices.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.There were no reports of any malfunction of the hf-resection electrode.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.Furthermore, a dhr review could not be performed since basic data of article identification (lot number) are missing.Instead a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE,
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10390455
• MDR Text Key: 210021290
• Report Number: 9610773-2020-00185
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention