MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE HOT BIOPSY FORCEPS

Model Number	SD-230U-20
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Despite several followup attempts by phone and in writing, there is no further information on the type of procedure, the tissue perforated, what role the reported failure to activate played in the perforation, whether the device was inspected before use, the additional surgical intervention, the patient¿s current condition, or the concomitant devices involved.As preventive measures, the device instruction manual contains several warning and caution statements for avoiding patient perforation: ¿do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view, do not use it.This could cause patient injury, such as perforation¿ ¿do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury, such as perforation¿ ¿do not angulate the bending section of the endoscope abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope.This could cause patient injury, such as perforation¿ ¿always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output levels or times may result in patient injury, such as perforation¿ ¿do not activate output when the distal end of the endoscope is too close to or in contact with the metal portion at the distal end of the forceps insertion portion.This could cause patient injury, such as perforation¿ and ¿aspirate fluids, such as mucus, that adhere to the distal end of the insertion portion and body cavity tissues.If output is activated with these fluids left attached, if could cause patient injury, such as perforation¿.The instruction manual also contains directions for pre-procedure inspection of the device, including visual and tactile inspection, and verification of mechanical operation.
Event or Problem Description
Olympus was informed that during an unknown procedure, the physician initially thought the device was not activating on the intended polyp tissue.The clinician later noticed that he had perforated past the mucosa and he was able to see the intestines.The patient had to be sent out for surgical intervention.The patient¿s current condition is unknown.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of oem device investigation and device history review.The device was returned to the oem for additional investigation.The investigation did not duplicate the complaint for not activating.The device passed conductivity testing.The dhr was also reviewed.The review found no manufacturing anomalies at the time of product release.Potential causes for the reported perforation are increased output from the separate generator and patient anatomical factors.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of device evaluation and device history review.The device model was verified to be sd-230u-20, disposable electrosurgical snare, not fd-230u as originally reported.The sd-230u-20 device was returned to olympus for initial evaluation.The evaluation did not duplicate the complaint for not activating.Using test equipment, the device was able to grasp and heat up sample tissue.The device also passed continuity testing.The snare loop was intact, and the slider was operational.
Additional Manufacturer Narrative
This report is being supplemented to correct the device product code in d2.

• Brand Name: DISPOSABLE HOT BIOPSY FORCEPS
• Common Device Name: DISPOSABLE HOT BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7915548
• Report Number: 2951238-2018-00581
• Device Sequence Number: 10977128
• Product Code: FDI
• UDI-Device Identifier: 04953170158766
• UDI-Public: 04953170158766
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K951445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/25/2022
• 2 Devices were Involved in the Event: 1 2

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: SD-230U-20
• Device Catalogue Number: SD-230U-20
• Device Lot Number: V7112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 11/30/2018; 08/18/2022
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/20/2018; 01/02/2019; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MODEL SCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown