MAUDE Adverse Event Report: BIOMERICS LLC RESECTRTM TISSUE RESECTION DEVICE; HYSTEROSCOPE ACCESSORIES

Model Number	M0065907051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 28, 2019 that a resector 5 fr was used in a polypectomy procedure in the uterus performed on (b)(6) 2019.According to the complainant, upon starting to shave the polyp the internal resecting blade broke off and fell inside the patient.Reportedly, it was successfully retrieved.The procedure was completed with a different device.There was no serious injury nor adverse patient effects as a result of this event.

• Brand Name: RESECTRTM TISSUE RESECTION DEVICE
• Common Device Name: HYSTEROSCOPE ACCESSORIES
• Manufacturer (Section D): BIOMERICS LLC; 6030 west harold gatty drive; salt lake city UT 84116
• MDR Report Key: 9811008
• Report Number: 3005099803-2020-00741
• Device Sequence Number: 19583885
• Product Code: NWW
• UDI-Device Identifier: 08714729964537
• UDI-Public: 08714729964537
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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 Expiration Date: 11/08/2020
• Device Model Number: M0065907051
• Device Catalogue Number: 74088
• Device Lot Number: 0009441380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1