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

Model Number	WA69300M
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
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 an unspecified therapeutic endoscopic procedure at an unknown date the patient sustained extensive burns.It was noticed that the base of the sheath of the forceps in use had exposed metal and was scorched.The intended procedure was canceled due to the burns.No further information was provided.The he replaced the forceps with another forceps and continued to complete the procedure.*there are no reports of treatment of burns by interrupting the procedure.Sheath model number unknown.Issue as a60800a.(b)(6) 2022 tatsumi (email from mr.(b)(6)).The defective product is wa69300m (lot number unknown).Surgery was canceled due to burns.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.During the investigation it was determined that the peek tube is deformed.The shaft insulation is shortened/has shrunk in its length and as a result has increased in its diameter along the shaft.Because of this phenomenon, the insulation can displace from its original position in the region of the rotating knob.Thus, the dielectric strength of the shaft insulation is no longer maintained due to exposed shaft tube at the proximal end.This was caused by a not tempered peek tube delivered by the supplier.Thus, the event/incident can be attributed to design and/or construction weakness.A manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.The case will be closed on olympus side and the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic endoscopic procedure at an unknown date the patient sustained extensive burns.It was noticed that the base of the sheath of the forceps in use had exposed metal and was scorched.The intended procedure was canceled due to the burns.No further information was provided.

• Brand Name: SHAFT "HICURA", 5 X 330, MONOPOLAR
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15672767
• Report Number: 9610773-2022-00505
• Device Sequence Number: 6372688
• Product Code: GEI
• UDI-Device Identifier: 04042761079112
• UDI-Public: 04042761079112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA69300M
• Device Catalogue Number: WA69300M
• Device Lot Number: 17YW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown