MAUDE Adverse Event Report: HOBBS MEDICAL, INC. HOBBS MEDICAL POLYPECTOMY SNARE

Model Number 4565OLY

Device Problems Break (1069); Material Separation (1562); Failure to Cut (2587); Difficult to Open or Close (2921)

Patient Problems Pain (1994); Perforation (2001)

Event Date 09/13/2021

Event Type  Injury  

Event Description

It was reported that the plastic sheet of the snare broke/split open and snare was unable to re-open/close during a polypectomy: this was the initial use of the snare.Users noticed that the snare was stiff and more difficult to open than usual.Within the cecum, fairly close to the appendiceal orifice was a sizable sessile polyp measuring about 2 cm long and 1 cm wide.It was injected with eleview to elevate it and complainants reported it looked like they had surrounded the entire polyp with a hot snare, but there was some dysfunction of the snare and it was not cauterizing properly so they could not cut through the polyp.They tried to remove the snare to grab the polyp with a new snare, but it was too embedded in the tissue.With some troubleshooting on the cautery machine, cautery was applied again and the polyp was removed.During the trouble shooting of the cautery not appearing to work (used erbe vio300d; monopolar pre-set settings for polypectomy 1a), the grounding pad light was green indicating that the pad was properly applied and there should be no reason for the cautery not to be working.Users then noticed on the distal end of the snare (closest to the assistance end), the plastic sheath that covers the wire was split open and the wire of the snare popped out.The wire had to be physically pushed back into the sheath in order to re-open the snare which was embedded into the tissue.The surgeon was then able to maneuver the snare (flip it over the polyp) in order to detach it from the tissue.Surgeon stated there was a little bit more burn artifact at the base of the polyp than expected so while they believe they removed the entire polyp in one pass, they stated it was a hard to be definitive because of the burn artifact.Patient was seen in the er 3-4 hours after the colonoscopy complaining of right lower quadrant.Patient was medivacced to another facility where ct scan confirmed free air.Patient started on iv antibiotics.Operation performed 1 day after colonoscopy: laparoscopic appendectomy, partial cecectomy.Patient recovered well and was discharged 3 days later.

• Brand Name: HOBBS MEDICAL POLYPECTOMY SNARE
• Type of Device: POLYPECTOMY SNARE
• Manufacturer (Section D): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer (Section G): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer Contact: jennifer hodge ; 8 spring street; stafford springs, CT 06076
• MDR Report Key: 12819816
• MDR Text Key: 280963004
• Report Number: 1220592-2021-00001
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K844074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 4565OLY
• Device Catalogue Number: 4565OLY
• Device Lot Number: H11-17-078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 63 YR
• Patient Sex: Male