MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HANDLE "HIQ+", INLINE A, ASYMMETRIC, RATCHET

Model Number	WA60120A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Therefore, the exact cause of the reported event could not be determined at this time.Based on the initial reported information it is unknown which device tip (handle or jaw insert) broke off.Olympus will continue to follow up with the user facility to obtain additional information regarding the reported event.As a preventive measure, the instruction manual provides a warning to mitigate the risk of patient injury and damage to the instrument which states, ¿the instrument¿s distal end is specially designed for bipolar coagulation and dissection.Do not use excessive force (bending, distorting, levering) when using the instrument.Otherwise instrument damage and patient injury may occur.¿ it also cautions user¿s the jaws may not contact each other during the procedure.Only activate hf current when the instrument is in direct contact with tissue.If there is no tissue contact, hf current may damage the instrument.
Event or Problem Description
Olympus was informed that during a laparoscopic abdominal hysterectomy, the doctor was inserting the device into the patient's abdominal cavity when the surgeon noticed the distal part of the "needle" broke off inside the patient.The surgeon was not able to locate the distal part of the device in the patient's abdominal cavity.The results of the patient's x-ray did not show evidence of any device fragments inside the patient's abdominal cavity.The intended procedure was completed using another device.There was no post surgery complications or injuries reported by the patient.
Additional Manufacturer Narrative
The original equipment manufacturer (oem) conducted a review of the manufacturing and quality control for the affected lot or serial number without showing any non-conformities or deviations.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information about the reported event.The manufacturer was further informed that the ¿distal part of the needle broken off¿ was first observed during the middle of the procedure.There was no device used during the procedure that generated energy.The bleeding was normal for the procedure.There were no issues withdrawing the device from the patient reported.The procedure lasted two hours.No longer stay was required.The instrument technician reported the device was used during the first surgery of the day and during the sterilization process no anomalies were observed.The device was used along with the ligasure¿ maryland jaw device and no energy was activated.After the procedure the device was damaged missing one side of the tip.

• Brand Name: HANDLE "HIQ+", INLINE A, ASYMMETRIC, RATCHET
• Common Device Name: HANDLE "HIQ+"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8583075
• Report Number: 2951238-2019-00794
• Device Sequence Number: 2935284
• Product Code: GCJ
• UDI-Device Identifier: 04042761031066
• UDI-Public: 04042761031066
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA60120A
• Device Catalogue Number: WA60120A
• Device Lot Number: 175W-OK3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 08/06/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/04/2019; 08/20/2019
• 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: 10MM TROCAR /SPIKE- KARL STORZ; 2X GRASP. FORCEPS- KARL STORZ, 5MM CLICK LINE; 5MM REDUCTION TUBE- KARL STORZ; 5MM TROCAR/SPIKE- KARL STORZ; ELECTRODE- KARL STORZ, 5MM HOOK; GRASP. FORCEPS- KARL STORZ, 10MM CLICK LINE; GRASP. FORCEPS- KARL STORZ, 5MM KELLY DISSECTING; INJECTION CANULA- KARL STORZ; MONOPOLAR HF CABLE- UNKNOWN; NEEDLE- VERRES; SCISSORS- KARL STORZ, 5MM CURVE; SILICONE TUBE KIT- NEUMO CABLE; SUCTION/IRRIGATION- KARL STORZ, 5MM CANULA