MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

Model Number M00546650

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spy followed by a plastic stenting procedure performed in the biliary duct on (b)(6) 2021.During the procedure, the spyscope was extracted from a duodenoscope and the light on the spyscope switched off.The spyscope was disconnected and reconnected back to the controller and the light turned on.After one minute, five points appeared on the screen and the image was lost.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a endoscopic retrograde cholangiopancreatography (ercp) with spy followed by a plastic stenting procedure performed in the biliary duct on (b)(6), 2021.During the procedure, the spyscope was extracted from duodenoscope and the light on the spyscope switched off.The spyscope was disconnected and reconnected back to the controller and the light turned on.After one minute, five points appeared on the screen and the image was lost.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.***additional information (b)(6)2021*** it was reported that the spyglass ds controller has been used and worked as intended since this event.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: additional information: b5.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11826055
• MDR Text Key: 250664318
• Report Number: 3005099803-2021-02267
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1