MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 430 MM, GRASPING FORCEPS, FENESTRATED, LONG; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	WA64121C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device will not be returned as it has been discarded.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
A customer reported to olympus that while using a jaws "hiq+", bipolar, 5 x 430 mm, grasping forceps, fenestrated, long, for an unspecified laparoscopic procedure, the fixed unit connecting the sleeve rod and the jaw fell off.It was later clarified that the jaw of the forceps broke and fell into the patient¿s body and was removed after localization by x-ray.The procedure was finished with a similar device.There was no additional patient injury or health damage.
Event or Problem Description
It was additionally reported that the procedure performed was for removal of ovarian cysts (non-malignant).The device fell into the abdominal cavity.It was reported that a grasping forceps was utilized to remove the jaw through the trocar.There was a procedural delay of 2-3 hours, but no injury or health damage occurred due to the delay.The patient was discharged normally.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b5 and h6.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the root cause of the reported event could not be determined.This supplemental report includes a correction to h8 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 430 MM, GRASPING FORCEPS, FENESTRATED, LONG
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17670289
• Report Number: 9610773-2023-02420
• Device Sequence Number: 7068387
• Product Code: HET
• UDI-Device Identifier: 04042761063487
• UDI-Public: 04042761063487
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

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: WA64121C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/06/2023; 10/13/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/07/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE "HIQ+", ERGO, BIPOLAR-LOT UNK.; SHAFT "HIQ+", BIPOLAR, 5 X 430 MM-LOT UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown