MAUDE Adverse Event Report: AESCULAP INC ROUND RING LARGE 318MM; GENERAL SURGICAL INSTRUMENTS

Model Number MB522

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results are received, they will be provided in a supplemental report.

Event Description

It was reported that there was an issue with large round ring.A bookwalter retractor, purchased in (b)(6) 2020, was used during an unspecified procedure.The surgeon had difficulty with the ratchets fitting correctly on the rings.A ratchet came off and fell into a patient.The ratchet was retrieved with the help of the blade.Additional information was not provided.The ring and tilting blade clamp were returned to the manufacturer.The malfunction is filed under xc reference (b)(4).Associated medwatches: 2916714-2021-00139.

Manufacturer Narrative

Investigation results: we received two additional table clamps and one round ring (mb522).The devices were sent back to the manufacturer for full investigation and a health hazard analysis.The manufacturer tested the ring with the clamps that were sent back and with current stock.The ring appeared to be slightly out of tolerance at one point on the ring but was conforming at all other points.It was determined that this minor deviation was not the cause of the reported error.The deviation caused the clamp to be stuck on the ring and difficult to move.Alternatively, if the deviation had caused the clamp to fit loosely on the ring, then a correlation could exist between the deviation and the clamp falling into the patient.Improper setup of the clamp onto the ring is more likely to have caused the device to fall off the ring and into the patient.The manufacturer determined that when these devices (mb510) are properly mounted to the ring (mb522), the reported error is not likely to be reproducible.Corrective and preventive actions: 1.Upon receiving notification of the reported complaint, mb510 and mb522 were held for containment and not sold until the closure of this investigation.2.A trending analysis was conducted and indicated the following: (b)(4).3.A health hazard analysis was conducted, and the results indicated that the reported error was not likely to occur and that the potential risk if it did occur to be limited/ transient.Since the root cause analysis indicated that the cause of the reported error was not manufacturing-related, the need for a mdr or product recall was ruled out.4.To address the out of tolerance issue, the manufacturer updated their inspection protocols.Their current protocols only required one point to be tested during final inspection.Their updated protocol calls for four different test points during final inspection.Device disposition: the manufacturer reworked the ring to fix the deviation that was found.

Event Description

Associated medwatches: 2916714-2021-00139 2916714-2021-00143.

• Brand Name: ROUND RING LARGE 318MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 12259923
• MDR Text Key: 264534768
• Report Number: 2916714-2021-00143
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04046964567636
• UDI-Public: 4046964567636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MB522
• Device Catalogue Number: MB522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention