MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, JOHANN LONG; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	WA64130A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience 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 a therapeutic laparoscopic subtotal gastrectomy in combination with a (roux-en-y) gastric bypass (rygb) procedure, one jaw got detached from the jaws insert and fell inside the patient's body cavity.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively 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.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.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, JOHANN LONG
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7876319
• Report Number: 9610773-2018-00086
• Device Sequence Number: 10811062
• Product Code: GCJ
• UDI-Device Identifier: 04042761030717
• UDI-Public: 04042761030717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944201
• 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): 11/07/2018

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: WA64130A
• Device Catalogue Number: WA64130A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1