MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, PRECISION SCISSORS, MONOPOLAR; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	WA69378M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Bowel Perforation (2668)
Date of Event	11/20/2020
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 after a therapeutic laparoscopic procedure the patient was not feeling well and had to undergo an emergency procedure during which it was discovered that the patient had burns and perforations in the small intestine.No further information was provided but there were no reports of any device malfunctions during the initial procedure.
Additional Manufacturer Narrative
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 conclusively determined and is being judged as unknown.However, the jaws insert and all other concomitant olympus devices were reportedly examined at the user facility without showing any defects that may have caused or contributed to the reported event.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 of the jaws insert.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: JAWS INSERT "HICURA", 5 X 330, PRECISION SCISSORS, MONOPOLAR
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10913198
• Report Number: 9610773-2020-00280
• Device Sequence Number: 19637593
• Product Code: GEI
• UDI-Device Identifier: 04042761083652
• UDI-Public: 04042761083652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: WA69378M
• Device Catalogue Number: WA69378M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/27/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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 HANDLE "HICURA", SIZE M, MONOPOLAR; OLYMPUS SHAFT "HICURA", 5 X 330, MONOPOLAR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention