MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS "HIQ+", BIPOLAR, 5 X 330 MM, FENESTRATED, ERGO; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS

Model Number	WA63120C
Medical Device Problem Codes	Failure to Deliver Energy (1211); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
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 determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.In general, the occurrence of bleeding during or after a procedure is an expected and foreseeable side effect, clearly identified in labeling and risk assessment with justification of benefit.The case will be closed from olympus side but may be reopened if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified gynecological hysterectomy procedure at an unknown date, the suspect medical device was not performing as expected since it was not coagulating properly and the patient suffered from post-operative bleeding from uterine vessels.No further information was provided.

• Brand Name: GRASPING FORCEPS "HIQ+", BIPOLAR, 5 X 330 MM, FENESTRATED, ERGO
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 7479420
• Report Number: 9610773-2018-00039
• Device Sequence Number: 11097587
• Product Code: GEI
• UDI-Device Identifier: 04042761063067
• UDI-Public: 04042761063067
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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: WA63120C
• Device Catalogue Number: WA63120C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/02/2018
• 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 "HIQ+", ERGO, BIPOLAR (WA60101C); OLYMPUS JAWS "HIQ+", BIPOLAR (WA64120C); OLYMPUS SHAFT "HIQ+", BIPOLAR (A60800C)
• Outcome Attributed to Adverse Event: Required Intervention