Single Use Mechanical Lithotriptor V

Description of Event or Problem

It was reported that during a therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, the distal guidewire tip of the single use mechanical lithotriptor fell off. After the customer retrieved the first distal tip, a new box of single use mechanical lithotriptors was opened and a second attempt was made to break the stone using the replacement device; however, the second distal tip also fell off, and the tip could not be found in the patient's body. Upon follow up, the customer stated that the location of the first tip was confirmed under the endoscope and was retrieved using grasping forceps. On the other hand, the customer reportedly gave up after searching for the second tip using the endoscope and confirmed that the second tip was left in the patient's body to pass naturally. No diagnostic imaging was performed. The procedure was completed with a back-up device with a less than 30-minute delay. There were no reports of patient harm. The customer further confirmed that the guidewire tip detached after insertion into the endoscope. The customer also noted that the guidewire was still inserted into the guidewire tip during lithotripsy. There were no instances where the basket was rotated while the guidewire was still inserted into the guidewire tip. There were also no other situations in which the guidewire tip was subjected to stress. A total of 2 reports will be submitted. This report includes the first of 2 reportable events and will focus on the first lithotriptor.

Additional Manufacturer Narrative

Date of event is unknown. Additional information will be provided if available.The investigation is ongoing. A supplemental report will be submitted when the investigation is completed or if additional information becomes available.