MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; RFT GYN LAPAROSCOPY PACK

Model Number	DYNJ50858
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unknown number of hysteroscopy procedure a swab fell off into the patient's vaginas after approximately 20 seconds of being in use.The swabs were being used with betadine and hibiclens.The nurse in the room recognized immediately that the sponge was no longer attached to the stick and the sponge was manually retrieved with ring forceps with no additional impact to the patient or intervention required.The sample was not returned to the manufacturer for evaluation.No additional information is available.A root cause could not be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the sponge detached from the stick during use on multiple patients requiring manual retrieval.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: RFT GYN LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10402858
• Report Number: 1423395-2020-00018
• Device Sequence Number: 2960995
• Product Code: FDE
• UDI-Device Identifier: 10889942029136
• UDI-Public: 10889942029136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ50858
• Device Catalogue Number: DYNJ50858
• Device Lot Number: 20BMA338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention