MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LONG CLIP

Model Number	HX-610-135L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The distributor reported on behalf of the customer, during a procedure, when the long clip was activated, the clip stuck to the applicator when shooting.It did not stick to the mucosa.Two (2) long clips malfunctioned in the same manner during the procedure.The intended procedure was completed.The same device was not used to complete the procedure.No reported patient harm.There were two (2) occurrences at the facility on the same day with four (4) different long clips.This complaint is related to patient identifiers: (b)(6).
Additional Manufacturer Narrative
This is a supplemental report to correct the initial mdr.Additional information was received from the reporter.Upon further review, the initial mdr was sent in error.The issues are reported in patient identifiers (b)(6) (mfr # 8010047 ¿ 2021 - 10472) and (b)(6) (mfr # 8010047 - 2021 - 10474).

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12341369
• Report Number: 8010047-2021-10473
• Device Sequence Number: 4115873
• Product Code: PKL
• UDI-Device Identifier: 04953170209154
• UDI-Public: 04953170209154
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: HX-610-135L
• Device Lot Number: 11K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: APPLICATOR, MODEL # UNKNOWN; APPLICATOR, MODEL # UNKNOWN