MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number	HX-202UR
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clip has not been returned for evaluation; therefore, the cause of the reported event cannot be determined.Based on similar reported events related to the device, the operator's technique cannot be ruled out as a contributory factor.The instruction manual states: "before use, prepare, and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, or mucous membrane damage, and may result in more severe equipment damage." if additional information becomes available a supplemental report will be filed.The quickclip pro¿ is a hemostasis clip made of elgiloy to resist bending of the arms.It has an 11mm wide opening width and is mri conditional.The clip itself can pivot at the sheath connection allowing for smooth insertion and the ability to navigate complex scope positions.The sheath prevents damage to the working channel of the scope and should never be removed.This instrument has been designed to be used with an olympus endoscope for endoscopic clip placement within the gastrointestinal (gi) tract for the purposes of: 1.Endoscopic marking; 2.Hemostasis for mucosal/ submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, diverticula in the colon; 3.As a supplementary method, closure of gi tract luminal perforation < 20 mm that can be treated conservatively.
Event or Problem Description
It was reported that the hx-202ur.A quick clip pro "exploded" (broke apart) inside of a patient during an unspecified procedure.There was no patient harm reported.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8907136
• Report Number: 8010047-2019-02954
• Device Sequence Number: 2647482
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• Combination Product (Y/N): N
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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-202UR
• Device Lot Number: 93K
• 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: 07/22/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1