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

Model Number DYNJ50858

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2020

Event Type  malfunction  

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 Description

It was reported that the sponge detached from the stick during use on multiple patients requiring manual retrieval.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: RFT GYN LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il
• MDR Report Key: 10402858
• MDR Text Key: 203531932
• Report Number: 1423395-2020-00018
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942029136
• UDI-Public: 10889942029136
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ50858
• Device Catalogue Number: DYNJ50858
• Device Lot Number: 20BMA338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention