MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS

Model Number	WA69320M
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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for 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 colonoscopy procedure, the jaws at the distal end of the suspect medical device broke while gripping the large intestine and a fragment fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the distal end of the stationary jaw had broken off.Furthermore, there were considerable traces of stretching indicating mechanical overload.In addition, there is rust on one of the fracture surface areas.The cause of this damage and the breakage of the stationary jaw is most likely mechanical overload in combination with tear and wear.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7517541
• Report Number: 9610773-2018-00049
• Device Sequence Number: 16526229
• Product Code: GEI
• UDI-Device Identifier: 04042761079297
• UDI-Public: 04042761079297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: WA69320M
• Device Catalogue Number: WA69320M
• Device Lot Number: 159W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1